Stimulation in the OvaryNCT06879002
Comparing IVF/ICSI Cycle Outcomes of Post Ovulation Ovarian Stimulation Protocol With Elonva Without GnRH Antagonist to Follicular Phase Day 2 Stimulation Fixed Day 5 Antagonist Protocol
An observational study of Stimulation in the Ovary and IVF Outcome, run by ART Fertility Clinics LLC at 2 sites in United Arab Emirates.
Trial summary
There are several approaches to the timing of antagonist administration in IVF/ICSI cycles. The primary goal is indeed to prevent premature ovulation, which could jeopardize the success of the cycle There is an emerging concept that suggests that the progesterone produced by the corpus luteum (formed after ovulation)… 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
- Stimulation in the Ovary, IVF Outcome
- What is being tested?
- Ovarian stimulation with menstruation or after ovulation
- Type of treatment
- Injection or infusion
- How many people
- 252 participants
- Where
- 2 sitesUnited Arab Emirates
- Study dates
- 30 Dec 2026to 30 Dec 2027
- How long will I take part?
- 8 Weeks
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: Expected normal responder patients who undergo IVF/ICSI+PGT-A at ART Fertility Clinics Dubai \& Abu Dhabi are willing to participate in the study.
Who may be able to join
- Age 18 to 38 years old.
- Normal Menstrual cycle of 25-35 days.
- Body Weight 60to90 kg
- AMH>1.3 - <3 ng/m (Ferraretti and Gianaroli, 2014; Calzada et al., 2019) an antral follicle count (AFC) of >5 on menstrual cycle days 2-3,
Who cannot join
- History of premature ovulation
- Azoospermia
- PCOS
- Endometriosis AFS ¾
- Endometrioma
- Known chromosomal abnormalities
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates2 sites
ART Fertility Clinics LLC
Abu Dhabi
Jonalyn Edades, EMBA, +97126528000, jonalyn.edades@artfertilityclinics.com
Barbara Lawrenz, PhD, +97126528000, barbara.lawrenz@artfertilityclinics.com
ART Fertility Clinics LLC - Dubai
Dubai
Jonalyn Edades, EMBA, +97126528000, jonalyn.edades@artfertilityclinics.com
About this study
Official title: To Compare IVF/ICSI Cycle Outcomes of Post Ovulation Ovarian Stimulation Protocol With Elonva Without GnRH Antagonist to Follicular Phase Fixed Day 5 Antagonist Protocol
There are several approaches to the timing of antagonist administration in IVF/ICSI cycles. The primary goal is indeed to prevent premature ovulation, which could jeopardize the success of the cycle There is an emerging concept that suggests that the progesterone produced by the corpus luteum (formed after ovulation) might be sufficient to prevent further ovulation, obviating the need for antagonist or exogenous progesterone administration. This hypothesis relies on the natural regulatory mechanisms of the menstrual cycle to maintain a progesterone-dominated environment post-ovulation. We hypothesized that this approach would minimize treatment costs /burden without having an impact on the outcome.
- Conditions
- Stimulation in the Ovary, IVF Outcome
- Being tested
- Ovarian stimulation with menstruation or after ovulation
- Keywords
- progesterone, premature ovulation, ovarian stimulation, luteal stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ovarian stimulation with menstruation or after ovulationOther
Ovarian stimulation with menstruation or after ovulation
| Study group | Role | What they receive |
|---|---|---|
| Group A: - Follicular phase start of ovarian stimulation with Elonva | Patients considered for ovarian stimulation for IVF/ICSI will be informed and a CF will be given on the day of planning for IVF. In group one, the ovarian stimulation protocol would follow a fixed GnRH antagonist protocol with recombinant FSH, Corifolitropin alfa (Elova150 mcg) starting on day 2 of the menstrual cycle.
Group A: Day 2-3 of cycle: Estradiol, Progesterone, Luteinizing Hormone, Follicle stimulating hormone During stimulation: on day 8 of stimulation: Estradiol, Progesterone, Luteinizing Hormone, Follicle stimulating hormone on trigger day: Estradiol, Progesterone, Luteinizing Hormone, Follicle stimulating hormone
Final oocyte maturation will be administered when 3 follicles reach 17mm or more. Oocyte retrieval will be performed 36 hours after human chorionic gonadotropin (hCG5000 or 10000IU, choriomon, IBSA) plus GnRH-a (0.2 or 0.3 mg Gonapeptyl, Ferring) administration under transvaginal ultrasound guidance. Receives: Other: Ovarian stimulation with menstruation or after ovulation | |
| Group B: One day after the Positive LH kit test at home: E2 P4 LH FSH,BHCG | . In group two, Elona 150mcg is being administered after ovulation confirmation with home LH kits starting to be used around usual ovulation days, and be confirmed in clinic with LH rise, E2 drop and blood P4 more than 1ng/dl one day after LH kit is positive. The probability of spontaneous pregnancy will be ruled out by betaHCG test. In case a spontaneous pregnancy has been confirmed,we will not start the treatment . Furthermore, in case of sustained progesterone rise,repeated hCG tests will be performed throughout the stimulation cycle to monitor whether there is an early pregnancy or not. If so,the treatment will be cancelled/stopped to prevent the potential risks of stimulation medications during an early pregnancy.From stimulation Day 8 onwards, hormonal stimulation will continue with daily dose. The maximum injection dose for continuing treatment after the first 7 days will be 200 IU. (10) Final oocyte maturation will be administered when 3 follicles reach 17mm or more. Receives: Other: Ovarian stimulation with menstruation or after ovulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the Oocyte maturity, Fertilization rate, Blastulation rate, quality Euploidy rate, Premature ovulation rate, Number of injections used and costs
Measured: From enrollment to the end of treatment at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start30 Dec 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stimulation in the OvaryStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 252 participants (estimated)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- ART Fertility Clinics LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Farid Mojtahedi, ART Fertility Clinics LLC
- Investigators
- Barbara Lawrenz, PhD, Study director, ART Fertility Clinics LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06879002
- Sponsor's protocol ID
- 2409-ABU-015-MF
- Status last verified
- Jan 2026
- First submitted
- 11 Mar 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: upon request
Publications
Ata B, Kalafat E. Progestin-primed ovarian stimulation: for whom, when and how? Reprod Biomed Online. 2024 Feb;48(2):103639. doi: 10.1016/j.rbmo.2023.103639. Epub 2023 Oct 22.
PubMed 38159467Giles J, Cruz F, Garcia-Velasco JA. Progestin-primed ovarian stimulation. Curr Opin Obstet Gynecol. 2024 Jun 1;36(3):165-172. doi: 10.1097/GCO.0000000000000941. Epub 2024 Jan 30.
PubMed 38295019Glujovsky D, Pesce R, Miguens M, Sueldo CE, Lattes K, Ciapponi A. How effective are the non-conventional ovarian stimulation protocols in ART? A systematic review and meta-analysis. J Assist Reprod Genet. 2020 Dec;37(12):2913-2928. doi: 10.1007/s10815-020-01966-5. Epub 2020 Nov 21.
PubMed 33219862Kolibianakis EM, Venetis CA, Kalogeropoulou L, Papanikolaou E, Tarlatzis BC. Fixed versus flexible gonadotropin-releasing hormone antagonist administration in in vitro fertilization: a randomized controlled trial. Fertil Steril. 2011 Feb;95(2):558-62. doi: 10.1016/j.fertnstert.2010.05.052. Epub 2010 Jul 16.
PubMed 20637457
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare IVF/ICSI Cycle Outcomes of Post Ovulation Ovarian Stimulation Protocol With Elonva Without GnRH Antagonist to Follicular Phase Fixed Day 5 Antagonist Protocol
- ClinicalTrials.gov ID
- NCT06879002
- Acronym / sponsor ID
- 2409-ABU-015-MF
- Conditions
- Stimulation in the Ovary, IVF Outcome
- Keywords
- progesterone, premature ovulation, ovarian stimulation, luteal stimulation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- ART Fertility Clinics LLCUniversity, hospital or other
- Study start
- 30 Dec 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 17 Mar 2025 (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.
There are several approaches to the timing of antagonist administration in IVF/ICSI cycles. The primary goal is indeed to prevent premature ovulation, which could jeopardize the success of the cycle There is an emerging concept that suggests that the progesterone produced by the corpus luteum (formed after ovulation) might be sufficient to prevent further ovulation, obviating the need for antagonist or exogenous progesterone administration. This hypothesis relies on the natural regulatory mechanisms of the menstrual cycle to maintain a progesterone-dominated environment post-ovulation. We hypothesized that this approach would minimize treatment costs /burden without having an impact on the outcome.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: - Follicular phase start of ovarian stimulation with Elonva | – | Other: Ovarian stimulation with menstruation or after ovulationPatients considered for ovarian stimulation for IVF/ICSI will be informed and a CF will be given on the day of planning for IVF. In group one, the ovarian stimulation protocol would follow a fixed GnRH antagonist protocol with recombinant FSH, Corifolitropin alfa (Elova150 mcg) starting on day 2 of the menstrual cycle. Group A: Day 2-3 of cycle: Estradiol, Progesterone, Luteinizing Hormone, Follicle stimulating hormone During stimulation: on day 8 of stimulation: Estradiol, Progesterone, Luteinizing Hormone, Follicle stimulating hormone on trigger day: Estradiol, Progesterone, Luteinizing Hormone, Follicle stimulating hormone Final oocyte maturation will be administered when 3 follicles reach 17mm or more. Oocyte retrieval will be performed 36 hours after human chorionic gonadotropin (hCG5000 or 10000IU, choriomon, IBSA) plus GnRH-a (0.2 or 0.3 mg Gonapeptyl, Ferring) administration under transvaginal ultrasound guidance. |
| Group B: One day after the Positive LH kit test at home: E2 P4 LH FSH,BHCG | – | Other: Ovarian stimulation with menstruation or after ovulation. In group two, Elona 150mcg is being administered after ovulation confirmation with home LH kits starting to be used around usual ovulation days, and be confirmed in clinic with LH rise, E2 drop and blood P4 more than 1ng/dl one day after LH kit is positive. The probability of spontaneous pregnancy will be ruled out by betaHCG test. In case a spontaneous pregnancy has been confirmed,we will not start the treatment . Furthermore, in case of sustained progesterone rise,repeated hCG tests will be performed throughout the stimulation cycle to monitor whether there is an early pregnancy or not. If so,the treatment will be cancelled/stopped to prevent the potential risks of stimulation medications during an early pregnancy.From stimulation Day 8 onwards, hormonal stimulation will continue with daily dose. The maximum injection dose for continuing treatment after the first 7 days will be 200 IU. (10) Final oocyte maturation will be administered when 3 follicles reach 17mm or more. |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Expected normal responder patients who undergo IVF/ICSI+PGT-A at ART Fertility Clinics Dubai \& Abu Dhabi are willing to participate in the study.
Key inclusion criteria (4 listed)
- Age 18 to 38 years old.
- Normal Menstrual cycle of 25-35 days.
- Body Weight 60to90 kg
- AMH>1.3 - <3 ng/m (Ferraretti and Gianaroli, 2014; Calzada et al., 2019) an antral follicle count (AFC) of >5 on menstrual cycle days 2-3,
Key exclusion criteria (6 listed)
- History of premature ovulation
- Azoospermia
- PCOS
- Endometriosis AFS ¾
- Endometrioma
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 |
|---|---|---|
| Ovarian stimulation with menstruation or after ovulationOvarian stimulation with menstruation or after ovulation | Other | Group A: - Follicular phase start of ovarian stimulation with Elonva, Group B: One day after the Positive LH kit test at home: E2 P4 LH FSH,BHCG |
Primary outcome
Evaluate the Oocyte maturity, Fertilization rate, Blastulation rate, quality Euploidy rate, Premature ovulation rate, Number of injections used and costs
Time frame: From enrollment to the end of treatment at 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 38159467Ata B, Kalafat E. Progestin-primed ovarian stimulation: for whom, when and how? Reprod Biomed Online. 2024 Feb;48(2):103639. doi: 10.1016/j.rbmo.2023.103639. Epub 2023 Oct 22.
- Background: PubMed 38295019Giles J, Cruz F, Garcia-Velasco JA. Progestin-primed ovarian stimulation. Curr Opin Obstet Gynecol. 2024 Jun 1;36(3):165-172. doi: 10.1097/GCO.0000000000000941. Epub 2024 Jan 30.
- Background: PubMed 33219862Glujovsky D, Pesce R, Miguens M, Sueldo CE, Lattes K, Ciapponi A. How effective are the non-conventional ovarian stimulation protocols in ART? A systematic review and meta-analysis. J Assist Reprod Genet. 2020 Dec;37(12):2913-2928. doi: 10.1007/s10815-020-01966-5. Epub 2020 Nov 21.
- Background: PubMed 20637457Kolibianakis EM, Venetis CA, Kalogeropoulou L, Papanikolaou E, Tarlatzis BC. Fixed versus flexible gonadotropin-releasing hormone antagonist administration in in vitro fertilization: a randomized controlled trial. Fertil Steril. 2011 Feb;95(2):558-62. doi: 10.1016/j.fertnstert.2010.05.052. Epub 2010 Jul 16.
- Individual participant dataSharing planned: Undecided. upon request
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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.
Barbara Lawrenz, PhD study director
ART Fertility Clinics LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stimulation in the Ovary and IVF Outcome, run by ART Fertility Clinics LLC at 2 sites 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 6 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: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonalyn Edades, EMBA (+97126528000, jonalyn.edades@artfertilityclinics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the Oocyte maturity, Fertilization rate, Blastulation rate, quality Euploidy rate, Premature ovulation rate, Number of injections used and costs (time frame: From enrollment to the end of treatment at 8 weeks). 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 NCT06879002, which also lists 4 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 7 May 2026.