Ovarian Function InsufficiencyPhase 1NCT05330130
Impact of FSH Dosage During Ovarian Stimulation for IVF/ICSI in Granulosa Cells
A Phase 1 study testing Follitropin beta injection 150 IU and Follitropin beta injection 300 IU in people with Ovarian Function Insufficiency and Fertility Issues, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
Trial summary
To study the influence of different daily rec-FSH dosages (150 IU versus 300 IU), performed in the same patient in consecutive cycles, on the relation between FSH- and LH-receptors of the granulosa cells of the growing follicle. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ovarian Function Insufficiency, Fertility Issues, Infertility,Female
- What is being tested?
- Follitropin beta injection 150 IU and Follitropin beta injection 300 IU
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 5 Jul 2023to 30 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Desire to perform oocyte freezing for social fertility preservation, age 18 - 38 years
- BMI of 18-32 kg/m2
- Regular menstrual cycles with a length of 24-35 days
- Anti-Muellerian-Hormone levels between 1.3 - 6.25 ng/ml (Ferraretti and Gianaroli, 2014; Calzada et al., 2019)
Who cannot join
- Occurrence of ovarian hyperstimulation syndrome (OHSS)
- Occurrence of poor ovarian response (AFC < 5 and AMH < 0,5ng/ml) in previous ovarian stimulation treatment (20)
- Polycystic ovary syndrome (PCOS) (21)
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
ART Fertility Clinics LLC
Abu Dhabi, 60202
About this study
Official title: Impact of FSH Dosage During Ovarian Stimulation for IVF/ICSI on the Expression of FSH- and LH-receptors in Granulosa Cells
To study the influence of different daily rec-FSH dosages (150 IU versus 300 IU), performed in the same patient in consecutive cycles, on the relation between FSH- and LH-receptors of the granulosa cells of the growing follicle.
Read the detailed description
This is a prospective cross-over study. Investigators want to study the effect of different dosages of recombinant FSH in the same patient on the expression of the FSH- and LH-receptors in the granulosa cells and on the endocrine milieu in the blood and the follicular fluid. An improved understanding of the mechanism leading to progesterone elevation might initiate a change in the ovarian stimulation approach, thereby not only preventing progesterone elevation and its negative consequences on ART (Assisted Reproductive Technology) outcome, but also improving individualization of the ovarian stimulation treatment according to the patients' characteristics.
- Being tested
- Follitropin beta injection 150 IU, Follitropin beta injection 300 IU
- Keywords
- Ovarian stimulation, Granulosa cells, Follicle Stimulating Hormone Receptor, Luteinising Hormone Receptor, Elevated progesterone
- Medical subject headings
- Infertility, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follitropin beta injection 150 IUDrug
Also called FOLLISTIM AQ
Participants commence ovarian stimulation on day 2 or 3 of their menstrual cycle with a daily dosage of 150 IU rec-FSH. The dosage will remain constant throughout the course of the stimulation. From the morning of the 5th stimulation day, GnRH-antagonist will be administered daily to prevent LH-rise. As soon as ≥ 3 follicle of a size of 17mm are seen, 0.3 mg GnRH-Agonist will be administered for final oocyte maturation. During ovarian stimulation, follicle puncture procedures with the aspiration of follicular fluid will be performed at the following time:
- one follicle on the morning of day 5, before the administration of the first GnRH-antagonist
- one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm
- two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation.
Oocyte retrieval of all other follicles will be carried out 36 hours after injection of the medication for final oocyte maturation.
Follitropin beta injection 300 IUDrug
Also called FOLLISTIM AQ
Participants commence ovarian stimulation on day 2 or 3 of their menstrual cycle with a daily dosage of 300 IU rec-FSH. The dosage will remain constant throughout the course of the stimulation. From the morning of the 5th stimulation day, GnRH-antagonist will be administered daily to prevent LH-rise. As soon as ≥ 3 follicle of a size of 17mm are seen, 0.3 mg GnRH-Agonist will be administered for final oocyte maturation. During ovarian stimulation, follicle puncture procedures with the aspiration of follicular fluid will be performed at the following time:
- one follicle on the morning of day 5, before the administration of the first GnRH-antagonist
- one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm
- two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation.
Oocyte retrieval of all other follicles will be carried out 36 hours after injection of the medication for final oocyte maturation.
| Study group | Role | What they receive |
|---|---|---|
| Daily 150 IU recFSH | Active comparator | Follitropin beta injection 150 IU daily Receives: Drug: Follitropin beta injection 150 IU |
| Daily 300 IU recFSH | Active comparator | Follitropin beta injection 300 IU daily Receives: Drug: Follitropin beta injection 300 IU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of FSHR- and LHR of the GC, obtained from one follicle on the morning of day 5, before the administration of the first GnRH-antagonist, punctured during the ovarian stimulation cycle
Measured: 5 days
Number of FSHR- and LHR of the GC, obtained from tone follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm, punctured during the ovarian stimulation cycle
Measured: 1 day
Number of FSHR- and LHR of the GC, obtained from two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation, punctured during the ovarian stimulation cycle
Measured: 1 day
Number of FSHR- and LHR of the GC, obtained from the follicular fluid of follicles aspirated during OPU
Measured: 1 day
Secondary outcomes (32)
Level of E2 hormone in the blood, the morning of day 5, before the administration of the first GnRH-antagonist
Measured: 5 days
Level of P4 hormone in the blood, the morning of day 5, before the administration of the first GnRH-antagonist
Measured: 5 days
Level of FSH hormone in the blood, the morning of day 5, before the administration of the first GnRH-antagonist
Measured: 5 days
Level of LH hormone in the blood, the morning of day 5, before the administration of the first GnRH-antagonist
Measured: 5 days
Level of E2 hormone in the blood, when there are at least 2 to 3 follicles with a size of 12 to 14 mm
Measured: 1 day
Level of P4 hormone in the blood, when there are at least 2 to 3 follicles with a size of 12 to 14 mm
Measured: 1 day
Level of FSH hormone in the blood, when there are at least 2 to 3 follicles with a size of 12 to 14 mm
Measured: 1 day
Level of LH hormone in the blood, when there are at least 2 to 3 follicles with a size of 12 to 14 mm
Measured: 1 day
Level of E2 hormone in the blood, on the morning of the day of final oocyte maturation
Measured: 1 day
Level of P4 hormone in the blood, on the morning of the day of final oocyte maturation
Measured: 1 day
Level of FSH hormone in the blood, on the morning of the day of final oocyte maturation
Measured: 1 day
Level of LH hormone in the blood, on the morning of the day of final oocyte maturation
Measured: 1 day
Level of E2 hormone in the blood, on the day of OPU
Measured: 1 day
Level of P4 hormone in the blood, on the day of OPU
Measured: 1 day
Level of FSH hormone in the blood, on the day of OPU
Measured: 1 day
Level of LH hormone in the blood, on the day of OPU
Measured: 1 day
Level of E2 hormone in the follicular fluid of one follicle on the morning of day 5, before the administration of the first GnRH-antagonist
Measured: 5 days
Level of P4 hormone in the follicular fluid of one follicle on the morning of day 5, before the administration of the first GnRH-antagonist
Measured: 5 days
Level of FSH hormone in the follicular fluid of one follicle on the morning of day 5, before the administration of the first GnRH-antagonist
Measured: 5 days
Level of LH hormone in the follicular fluid of one follicle on the morning of day 5, before the administration of the first GnRH-antagonist
Measured: 5 days
Level of E2 hormone in the follicular fluid of one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm
Measured: 1 day
Level of P4 hormone in the follicular fluid of one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm
Measured: 1 day
Level of FSH hormone in the follicular fluid of one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm
Measured: 1 day
Level of LH hormone in the follicular fluid of one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm
Measured: 1 day
Level of E2 hormone in the follicular fluid of two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation
Measured: 1 day
Level of P4 hormone in the follicular fluid of two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation
Measured: 1 day
Level of FSH hormone in the follicular fluid of two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation
Measured: 1 day
Level of LH hormone in the follicular fluid of two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation
Measured: 1 day
Level of E2 hormone in the follicular fluid of follicles aspirated during OPU
Measured: 1 day
Level of P4 hormone in the follicular fluid of follicles aspirated during OPU
Measured: 1 day
Level of FSH hormone in the follicular fluid of follicles aspirated during OPU
Measured: 1 day
Level of LH hormone in the follicular fluid of follicles aspirated during OPU
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start5 Jul 2023
- Primary completion30 Mar 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Ovarian Function InsufficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- ART Fertility Clinics LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Organon and Co
- Responsible party
- Principal investigator, Barbara Lawrenz, ART Fertility Clinics LLC
- Investigators
- Barbara Lawrenz, PhD, Principal investigator, ART Fertility Clinics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330130
- Sponsor's protocol ID
- 2107-ABU-010-BL
- Status last verified
- Jan 2025
- First submitted
- 31 Mar 2022
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Baker VL, Brown MB, Luke B, Smith GW, Ireland JJ. Gonadotropin dose is negatively correlated with live birth rate: analysis of more than 650,000 assisted reproductive technology cycles. Fertil Steril. 2015 Nov;104(5):1145-52.e1-5. doi: 10.1016/j.fertnstert.2015.07.1151. Epub 2015 Aug 18.
PubMed 26297646Bosch E, Valencia I, Escudero E, Crespo J, Simon C, Remohi J, Pellicer A. Premature luteinization during gonadotropin-releasing hormone antagonist cycles and its relationship with in vitro fertilization outcome. Fertil Steril. 2003 Dec;80(6):1444-9. doi: 10.1016/j.fertnstert.2003.07.002.
PubMed 14667881Calzada M, Lopez N, Noguera JA, Mendiola J, Hernandez AI, Corbalan S, Sanchez M, Torres AM. AMH in combination with SHBG for the diagnosis of polycystic ovary syndrome. J Obstet Gynaecol. 2019 Nov;39(8):1130-1136. doi: 10.1080/01443615.2019.1587604. Epub 2019 Jun 17.
PubMed 31208261Erickson GF, Wang C, Hsueh AJ. FSH induction of functional LH receptors in granulosa cells cultured in a chemically defined medium. Nature. 1979 May 24;279(5711):336-8. doi: 10.1038/279336a0. No abstract available.
PubMed 221826Fauser BC. Towards the global coverage of a unified registry of IVF outcomes. Reprod Biomed Online. 2019 Feb;38(2):133-137. doi: 10.1016/j.rbmo.2018.12.001. Epub 2018 Dec 14. No abstract available.
PubMed 30593441Ferraretti AP, Gianaroli L. The Bologna criteria for the definition of poor ovarian responders: is there a need for revision? Hum Reprod. 2014 Sep;29(9):1842-5. doi: 10.1093/humrep/deu139. Epub 2014 Jul 9.
PubMed 25008235Filicori M, Cognigni GE, Gamberini E, Parmegiani L, Troilo E, Roset B. Efficacy of low-dose human chorionic gonadotropin alone to complete controlled ovarian stimulation. Fertil Steril. 2005 Aug;84(2):394-401. doi: 10.1016/j.fertnstert.2005.02.036.
PubMed 16084880Huang B, Ren X, Wu L, Zhu L, Xu B, Li Y, Ai J, Jin L. Elevated Progesterone Levels on the Day of Oocyte Maturation May Affect Top Quality Embryo IVF Cycles. PLoS One. 2016 Jan 8;11(1):e0145895. doi: 10.1371/journal.pone.0145895. eCollection 2016.
PubMed 26745711Jeppesen JV, Kristensen SG, Nielsen ME, Humaidan P, Dal Canto M, Fadini R, Schmidt KT, Ernst E, Yding Andersen C. LH-receptor gene expression in human granulosa and cumulus cells from antral and preovulatory follicles. J Clin Endocrinol Metab. 2012 Aug;97(8):E1524-31. doi: 10.1210/jc.2012-1427. Epub 2012 Jun 1.
PubMed 22659248Lawrenz B, Beligotti F, Engelmann N, Gates D, Fatemi HM. Impact of gonadotropin type on progesterone elevation during ovarian stimulation in GnRH antagonist cycles. Hum Reprod. 2016 Nov;31(11):2554-2560. doi: 10.1093/humrep/dew213. Epub 2016 Sep 12.
PubMed 27619773Lawrenz B, Fatemi HM. Effect of progesterone elevation in follicular phase of IVF-cycles on the endometrial receptivity. Reprod Biomed Online. 2017 Apr;34(4):422-428. doi: 10.1016/j.rbmo.2017.01.011. Epub 2017 Jan 24.
PubMed 28162937Lawrenz B, Labarta E, Fatemi H, Bosch E. Premature progesterone elevation: targets and rescue strategies. Fertil Steril. 2018 Apr;109(4):577-582. doi: 10.1016/j.fertnstert.2018.02.128.
PubMed 29653703Lawrenz B, Melado L, Fatemi H. Premature progesterone rise in ART-cycles. Reprod Biol. 2018 Mar;18(1):1-4. doi: 10.1016/j.repbio.2018.01.001. Epub 2018 Jan 6.
PubMed 29317175Macklon NS, Stouffer RL, Giudice LC, Fauser BC. The science behind 25 years of ovarian stimulation for in vitro fertilization. Endocr Rev. 2006 Apr;27(2):170-207. doi: 10.1210/er.2005-0015. Epub 2006 Jan 24.
PubMed 16434510Munch EM, Sparks AE, Zimmerman MB, Van Voorhis BJ, Duran EH. High FSH dosing is associated with reduced live birth rate in fresh but not subsequent frozen embryo transfers. Hum Reprod. 2017 Jul 1;32(7):1402-1409. doi: 10.1093/humrep/dex094.
PubMed 28472321
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of FSH Dosage During Ovarian Stimulation for IVF/ICSI on the Expression of FSH- and LH-receptors in Granulosa Cells
- ClinicalTrials.gov ID
- NCT05330130
- Acronym / sponsor ID
- 2107-ABU-010-BL
- Keywords
- Ovarian stimulation, Granulosa cells, Follicle Stimulating Hormone Receptor, Luteinising Hormone Receptor, Elevated progesterone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- ART Fertility Clinics LLCUniversity, hospital or other
- Collaborators
- Organon and Co
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 15 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To study the influence of different daily rec-FSH dosages (150 IU versus 300 IU), performed in the same patient in consecutive cycles, on the relation between FSH- and LH-receptors of the granulosa cells of the growing follicle.
Detailed description
This is a prospective cross-over study. Investigators want to study the effect of different dosages of recombinant FSH in the same patient on the expression of the FSH- and LH-receptors in the granulosa cells and on the endocrine milieu in the blood and the follicular fluid. An improved understanding of the mechanism leading to progesterone elevation might initiate a change in the ovarian stimulation approach, thereby not only preventing progesterone elevation and its negative consequences on ART (Assisted Reproductive Technology) outcome, but also improving individualization of the ovarian stimulation treatment according to the patients' characteristics.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Daily 150 IU recFSH | Active comparator | Drug: Follitropin beta injection 150 IUFollitropin beta injection 150 IU daily |
| Daily 300 IU recFSH | Active comparator | Drug: Follitropin beta injection 300 IUFollitropin beta injection 300 IU daily |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Desire to perform oocyte freezing for social fertility preservation, age 18 - 38 years
- BMI of 18-32 kg/m2
- Regular menstrual cycles with a length of 24-35 days
- Anti-Muellerian-Hormone levels between 1.3 - 6.25 ng/ml (Ferraretti and Gianaroli, 2014; Calzada et al., 2019)
Key exclusion criteria (3 listed)
- Occurrence of ovarian hyperstimulation syndrome (OHSS)
- Occurrence of poor ovarian response (AFC < 5 and AMH < 0,5ng/ml) in previous ovarian stimulation treatment (20)
- Polycystic ovary syndrome (PCOS) (21)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follitropin beta injection 150 IUAlso: FOLLISTIM AQParticipants commence ovarian stimulation on day 2 or 3 of their menstrual cycle with a daily dosage of 150 IU rec-FSH. The dosage will remain constant throughout the course of the stimulation. From the morning of the 5th stimulation day, GnRH-antagonist will be administered daily to prevent LH-rise. As soon as ≥ 3 follicle of a size of 17mm are seen, 0.3 mg GnRH-Agonist will be administered for final oocyte maturation. During ovarian stimulation, follicle puncture procedures with the aspiration of follicular fluid will be performed at the following time: * one follicle on the morning of day 5, before the administration of the first GnRH-antagonist * one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm * two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation. Oocyte retrieval of all other follicles will be carried out 36 hours after injection of the medication for final oocyte maturation. | Drug | Daily 150 IU recFSH |
| Follitropin beta injection 300 IUAlso: FOLLISTIM AQParticipants commence ovarian stimulation on day 2 or 3 of their menstrual cycle with a daily dosage of 300 IU rec-FSH. The dosage will remain constant throughout the course of the stimulation. From the morning of the 5th stimulation day, GnRH-antagonist will be administered daily to prevent LH-rise. As soon as ≥ 3 follicle of a size of 17mm are seen, 0.3 mg GnRH-Agonist will be administered for final oocyte maturation. During ovarian stimulation, follicle puncture procedures with the aspiration of follicular fluid will be performed at the following time: * one follicle on the morning of day 5, before the administration of the first GnRH-antagonist * one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm * two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation. Oocyte retrieval of all other follicles will be carried out 36 hours after injection of the medication for final oocyte maturation. | Drug | Daily 300 IU recFSH |
Primary outcome
Number of FSHR- and LHR of the GC, obtained from one follicle on the morning of day 5, before the administration of the first GnRH-antagonist, punctured during the ovarian stimulation cycle
Time frame: 5 days
Number of FSHR- and LHR of the GC, obtained from tone follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm, punctured during the ovarian stimulation cycle
Time frame: 1 day
Number of FSHR- and LHR of the GC, obtained from two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation, punctured during the ovarian stimulation cycle
Time frame: 1 day
Number of FSHR- and LHR of the GC, obtained from the follicular fluid of follicles aspirated during OPU
Time frame: 1 day
32 secondary outcomes
Level of E2 hormone in the blood, the morning of day 5, before the administration of the first GnRH-antagonist
Time frame: 5 days
Level of P4 hormone in the blood, the morning of day 5, before the administration of the first GnRH-antagonist
Time frame: 5 days
Level of FSH hormone in the blood, the morning of day 5, before the administration of the first GnRH-antagonist
Time frame: 5 days
Level of LH hormone in the blood, the morning of day 5, before the administration of the first GnRH-antagonist
Time frame: 5 days
Level of E2 hormone in the blood, when there are at least 2 to 3 follicles with a size of 12 to 14 mm
Time frame: 1 day
Level of P4 hormone in the blood, when there are at least 2 to 3 follicles with a size of 12 to 14 mm
Time frame: 1 day
Level of FSH hormone in the blood, when there are at least 2 to 3 follicles with a size of 12 to 14 mm
Time frame: 1 day
Level of LH hormone in the blood, when there are at least 2 to 3 follicles with a size of 12 to 14 mm
Time frame: 1 day
Level of E2 hormone in the blood, on the morning of the day of final oocyte maturation
Time frame: 1 day
Level of P4 hormone in the blood, on the morning of the day of final oocyte maturation
Time frame: 1 day
Level of FSH hormone in the blood, on the morning of the day of final oocyte maturation
Time frame: 1 day
Level of LH hormone in the blood, on the morning of the day of final oocyte maturation
Time frame: 1 day
Level of E2 hormone in the blood, on the day of OPU
Time frame: 1 day
Level of P4 hormone in the blood, on the day of OPU
Time frame: 1 day
Level of FSH hormone in the blood, on the day of OPU
Time frame: 1 day
Level of LH hormone in the blood, on the day of OPU
Time frame: 1 day
Level of E2 hormone in the follicular fluid of one follicle on the morning of day 5, before the administration of the first GnRH-antagonist
Time frame: 5 days
Level of P4 hormone in the follicular fluid of one follicle on the morning of day 5, before the administration of the first GnRH-antagonist
Time frame: 5 days
Level of FSH hormone in the follicular fluid of one follicle on the morning of day 5, before the administration of the first GnRH-antagonist
Time frame: 5 days
Level of LH hormone in the follicular fluid of one follicle on the morning of day 5, before the administration of the first GnRH-antagonist
Time frame: 5 days
Level of E2 hormone in the follicular fluid of one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm
Time frame: 1 day
Level of P4 hormone in the follicular fluid of one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm
Time frame: 1 day
Level of FSH hormone in the follicular fluid of one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm
Time frame: 1 day
Level of LH hormone in the follicular fluid of one follicle of the size of 12 to 14 mm, when at least 2 to 3 follicles have reached a size of 12 to 14 mm
Time frame: 1 day
Level of E2 hormone in the follicular fluid of two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation
Time frame: 1 day
Level of P4 hormone in the follicular fluid of two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation
Time frame: 1 day
Level of FSH hormone in the follicular fluid of two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation
Time frame: 1 day
Level of LH hormone in the follicular fluid of two follicles (= pre-ovulatory follicle) on the morning of the day of final oocyte maturation
Time frame: 1 day
Level of E2 hormone in the follicular fluid of follicles aspirated during OPU
Time frame: 1 day
Level of P4 hormone in the follicular fluid of follicles aspirated during OPU
Time frame: 1 day
Level of FSH hormone in the follicular fluid of follicles aspirated during OPU
Time frame: 1 day
Level of LH hormone in the follicular fluid of follicles aspirated during OPU
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Background: PubMed 26297646Baker VL, Brown MB, Luke B, Smith GW, Ireland JJ. Gonadotropin dose is negatively correlated with live birth rate: analysis of more than 650,000 assisted reproductive technology cycles. Fertil Steril. 2015 Nov;104(5):1145-52.e1-5. doi: 10.1016/j.fertnstert.2015.07.1151. Epub 2015 Aug 18.
- Background: PubMed 14667881Bosch E, Valencia I, Escudero E, Crespo J, Simon C, Remohi J, Pellicer A. Premature luteinization during gonadotropin-releasing hormone antagonist cycles and its relationship with in vitro fertilization outcome. Fertil Steril. 2003 Dec;80(6):1444-9. doi: 10.1016/j.fertnstert.2003.07.002.
- Background: PubMed 31208261Calzada M, Lopez N, Noguera JA, Mendiola J, Hernandez AI, Corbalan S, Sanchez M, Torres AM. AMH in combination with SHBG for the diagnosis of polycystic ovary syndrome. J Obstet Gynaecol. 2019 Nov;39(8):1130-1136. doi: 10.1080/01443615.2019.1587604. Epub 2019 Jun 17.
- Background: PubMed 221826Erickson GF, Wang C, Hsueh AJ. FSH induction of functional LH receptors in granulosa cells cultured in a chemically defined medium. Nature. 1979 May 24;279(5711):336-8. doi: 10.1038/279336a0. No abstract available.
- Background: PubMed 30593441Fauser BC. Towards the global coverage of a unified registry of IVF outcomes. Reprod Biomed Online. 2019 Feb;38(2):133-137. doi: 10.1016/j.rbmo.2018.12.001. Epub 2018 Dec 14. No abstract available.
- Background: PubMed 25008235Ferraretti AP, Gianaroli L. The Bologna criteria for the definition of poor ovarian responders: is there a need for revision? Hum Reprod. 2014 Sep;29(9):1842-5. doi: 10.1093/humrep/deu139. Epub 2014 Jul 9.
- Background: PubMed 16084880Filicori M, Cognigni GE, Gamberini E, Parmegiani L, Troilo E, Roset B. Efficacy of low-dose human chorionic gonadotropin alone to complete controlled ovarian stimulation. Fertil Steril. 2005 Aug;84(2):394-401. doi: 10.1016/j.fertnstert.2005.02.036.
- Background: PubMed 26745711Huang B, Ren X, Wu L, Zhu L, Xu B, Li Y, Ai J, Jin L. Elevated Progesterone Levels on the Day of Oocyte Maturation May Affect Top Quality Embryo IVF Cycles. PLoS One. 2016 Jan 8;11(1):e0145895. doi: 10.1371/journal.pone.0145895. eCollection 2016.
- Background: PubMed 22659248Jeppesen JV, Kristensen SG, Nielsen ME, Humaidan P, Dal Canto M, Fadini R, Schmidt KT, Ernst E, Yding Andersen C. LH-receptor gene expression in human granulosa and cumulus cells from antral and preovulatory follicles. J Clin Endocrinol Metab. 2012 Aug;97(8):E1524-31. doi: 10.1210/jc.2012-1427. Epub 2012 Jun 1.
- Background: PubMed 27619773Lawrenz B, Beligotti F, Engelmann N, Gates D, Fatemi HM. Impact of gonadotropin type on progesterone elevation during ovarian stimulation in GnRH antagonist cycles. Hum Reprod. 2016 Nov;31(11):2554-2560. doi: 10.1093/humrep/dew213. Epub 2016 Sep 12.
- Background: PubMed 28162937Lawrenz B, Fatemi HM. Effect of progesterone elevation in follicular phase of IVF-cycles on the endometrial receptivity. Reprod Biomed Online. 2017 Apr;34(4):422-428. doi: 10.1016/j.rbmo.2017.01.011. Epub 2017 Jan 24.
- Background: PubMed 29653703Lawrenz B, Labarta E, Fatemi H, Bosch E. Premature progesterone elevation: targets and rescue strategies. Fertil Steril. 2018 Apr;109(4):577-582. doi: 10.1016/j.fertnstert.2018.02.128.
- Segaloff DL, Richards JS, Ascoli M, Wang H. Regulation of the LH/CG Receptor by Gonadotropins. In Hunzicker-Dunn M, Schwartz NB, editors. Follicle Stimul Horm \[Internet\] 1992;, p. 199-205. Springer New York: New York, NYLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Lawrenz, PhD principal investigator
ART Fertility Clinics LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Follitropin beta injection 150 IU and Follitropin beta injection 300 IU in people with Ovarian Function Insufficiency and Fertility Issues, run by ART Fertility Clinics LLC at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of FSHR- and LHR of the GC, obtained from one follicle on the morning of day 5, before the administration of the first GnRH-antagonist, punctured during the ovarian stimulation cycle (time frame: 5 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05330130, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.