InVitro FertilizationDYG-GONANCT07348757
rFSH vs rFSH+rLH in Dydrogesterone-Based Progestin Protocol: A Prospective Study
An observational study of InVitro Fertilization and Gonadotropins, run by Centrum Clinic IVF Center at 2 sites in Turkey (Türkiye).
Trial summary
This study aims to compare two commonly used hormone treatments for women undergoing IVF. All participants will receive a stimulation protocol that includes dydrogesterone, a medication used to safely control natural hormone surges during treatment. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- InVitro Fertilization, Gonadotropins
- How many people
- 202 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 5 Feb 2026to 20 Jun 2026
- How long will I take part?
- 5 Months
- Phase
- Observational
- 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 43 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Participants will be selected from women seeking infertility treatment at a fertility clinic and undergoing in-vitro fertilization (IVF) with controlled ovarian stimulation. This population typically consists of reproductive-age women who have difficulty achieving pregnancy and require assisted reproductive technologies. Eligible patients are generally healthy enough to undergo ovarian stimulation, have adequate ovarian reserve (AMH > 1 ng/mL), and meet age and BMI criteria for standard IVF care. Women in this group routinely receive dydrogesterone-based PPOS protocols as part of their clinical treatment, and the choice of gonadotropin regimen (rFSH alone or rFSH+rLH) follows routine medical practice. This population reflects real-world patients commonly treated in IVF programs
Who may be able to join
- Women aged 20 to 43 years.
- BMI < 30 kg/m².
- AMH > 1 ng/mL.
- Undergoing IVF/ICSI treatment with a dydrogesterone-based PPOS protocol.
- Women with regular menstrual cycles or clinically acceptable cycle pattern for stimulation.
- Ability to provide informed consent and comply with study procedures.
- Presence of at least one ovary and eligibility for controlled ovarian stimulation
Who cannot join
- Cycle cancellation due to lack of viable embryos.
- Prior or planned PGT-A in the same cycle.
- Adenomyosis diagnosed by ultrasound or MRI.
- Uncorrected uterine anomalies (e.g., bicornuate, unicornuate, didelphys uterus).
- Presence of hydrosalpinx.
- Use of oral contraceptives or luteal-phase estradiol within 3 months before stimulation.
Show all 9Show fewer
- Refusal or inability to provide informed consent.
- Severe systemic disease or contraindication to ovarian stimulation.
- Prior bilateral oophorectomy
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Centrum Clinic IVF Center
Ankara, Ankara, 06800
Bahçeci IVF Center
Ankara
About this study
Official title: Comparison of rFSH Alone Versus rFSH+rLH in Dydrogesterone-Based Progestin Protocol Cycles
This study aims to compare two commonly used hormone treatments for women undergoing IVF. All participants will receive a stimulation protocol that includes dydrogesterone, a medication used to safely control natural hormone surges during treatment. The study will observe women who are treated either with recombinant FSH alone or with a combination of recombinant FSH and recombinant LH-both routinely used options in our clinic.
Investigators will prospectively monitor how these treatments affect the growth of ovarian follicles, the number of mature eggs collected, the quality of developing embryos, and early pregnancy outcomes. No additional procedures or medications will be required beyond standard IVF care. The goal is to better understand whether adding recombinant LH provides any measurable benefit in dydrogesterone-based PPOS cycles.
Read the detailed description
This prospective observational study aims to evaluate how two routinely used gonadotropin strategies influence ovarian response and reproductive outcomes in women undergoing IVF treatment with a dydrogesterone-based Progestin-Primed Ovarian Stimulation (PPOS) protocol. In standard clinical practice, ovarian stimulation may be performed using recombinant FSH alone or a combination of recombinant FSH and recombinant LH. Both approaches are already used in daily care, and the choice of regimen is determined by the treating physician according to individual patient characteristics. The study does not assign treatments; instead, it observes and compares outcomes in patients receiving these medications as part of routine management.
Dydrogesterone is administered from Day 2 of the cycle to prevent premature LH surges, allowing controlled follicular growth. Participants will undergo regular ultrasound monitoring and bloodwork as part of their usual IVF treatment. When appropriate follicular maturation is achieved, final oocyte maturation will be triggered, followed by oocyte retrieval according to standard clinical protocols.
The primary focus of this study is to compare the number of mature (MII) oocytes obtained between the two gonadotropin regimens. Secondary outcomes include the number of good-quality blastocysts, implantation rate, and ongoing pregnancy rate, which together provide a comprehensive assessment of IVF success. Additional stimulation characteristics-such as follicle growth patterns, estradiol and LH levels, total gonadotropin dose, and duration of stimulation-will also be documented to explore differences in cycle dynamics.
No extra medications, procedures, or interventions will be required beyond routine IVF care. All data will be collected prospectively and analyzed to determine whether adding recombinant LH offers measurable clinical advantages compared with recombinant FSH alone in dydrogesterone-PPOS cycles.
- Conditions
- InVitro Fertilization, Gonadotropins
- Keywords
- gonadotropins, invitro fertilization, pregnancy, ppos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Recombinant FSH Only Group | Recombinant FSH (rFSH) Group - Additional Information Participants in this cohort will undergo ovarian stimulation using recombinant follicle-stimulating hormone (rFSH) alone, following routine IVF clinical practice. Dydrogesterone will be initiated on Cycle Day 2 as part of the standard PPOS (Progestin-Primed Ovarian Stimulation) protocol to prevent premature LH surge. Follicular development will be monitored with ultrasound and serum hormone levels, and the timing of final oocyte maturation and oocyte pick-up will follow standard clinical procedures. No additional medications or interventions will be administered beyond those routinely used for IVF treatment. | |
| Recombinant FSH Plus Recombinant LH Group | Recombinant FSH Plus Recombinant LH (2:1 Combination) Group - Additional Information Participants in this cohort will receive a combination of recombinant follicle-stimulating hormone (rFSH) and recombinant luteinizing hormone (rLH) in a fixed 2:1 ratio, as routinely used in clinical IVF practice. Dydrogesterone will be initiated on Cycle Day 2 according to the standard PPOS (Progestin-Primed Ovarian Stimulation) protocol to prevent premature LH surge. Follicular development will be monitored through ultrasound examinations and serum hormone measurements, and final oocyte maturation and oocyte retrieval will be performed following standard clinical procedures. No additional treatments or study-specific interventions will be administered beyond those normally used in IVF care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
numbers of top quality blastocysts
Top-quality blastocysts are defined according to the Gardner and Schoolcraft blastocyst grading system as blastocysts with full expansion (grade ≥3), an inner cell mass (ICM) grade of A or B, and a trophectoderm (TE) grade of A or B (i.e., grades ≥3BB)
Measured: day 5 after fertilization
mature oocytes collected (MII)
Time Frame:
From the date of participant enrollment, including initiation of controlled ovarian stimulation, through the completion of the oocyte pick-up (OPU) procedure, with the number of mature (metaphase II) oocytes assessed and recorded exclusively at the time of oocyte aspiration. The overall assessment period spans the duration of ovarian stimulation and scheduling of OPU, with a maximum observation period of up to 3-4 weeks
Measured: The overall assessment period spans the duration of ovarian stimulation and scheduling of oocyte aspiration, with a maximum observation period of up to 3-4 weeks
Secondary outcomes (3)
total numbers of blastocysts
The total number of blastocyst-stage embryos generated per cycle, defined as embryos that reach the blastocyst stage (Day 5 or Day 6) following in vitro fertilization or intracytoplasmic sperm injection (ICSI), and recorded after completion of embryo culture.
Time Frame
From the date of participant enrollment, including initiation of controlled ovarian stimulation, through completion of embryo culture to the blastocyst stage, with the total number of blastocysts assessed and recorded after final blastocyst evaluation (Day 5-6 embryo culture). The overall assessment period includes ovarian stimulation, oocyte pick-up (OPU), fertilization, and extended embryo culture, with a maximum observation period of up to 3-4 weeks.
Measured: From participant enrollment and initiation of ovarian stimulation through completion of embryo culture to the blastocyst stage, over a maximum period of up to 3-4 weeks.
Clinical pregnancy rate per embryo transfer
Clinical pregnancy rate per embryo transfer is defined as the proportion of embryo transfer cycles resulting in at least one intrauterine gestational sac with fetal cardiac activity confirmed by transvaginal ultrasound.
Unit: %
Measured: 6-7 weeks after embryo transfer
Live birth rate per embryo transfer (LBR per ET)
Live birth rate per embryo transfer is defined as the proportion of embryo transfer cycles resulting in the delivery of at least one live-born infant after ≥24 weeks of gestation.
Unit: percentage
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start5 Feb 2026
- Primary completion15 Jun 2026
- Study completion20 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InVitro FertilizationStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 202 participants (actual)
- Target duration
- 5 Months
Sponsor and investigators
- Lead sponsor
- Centrum Clinic IVF Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Göksan Pabuçcu, Centrum Clinic IVF Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07348757
- Sponsor's protocol ID
- 2025-11
- Acronym
- DYG-GONA
- Status last verified
- Jan 2026
- First submitted
- 19 Nov 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involves sensitive reproductive health information and data are collected solely for clinical and research purposes within the center. Only aggregated, de-identified results will be reported in publications. Supporting Documents to Be Shared: None.
Publications
Muharam R, Nurdya AN, Yo EC, Sumapraja K, Harzif AK, Maidarti M, Wiweko B, Hestiantoro A. Comparing Dydrogesterone Versus Medroxyprogesterone in Progestin-Primed Ovarian Stimulation (PPOS) for Patients Undergoing In Vitro Fertilization/Intracytoplasmic Sperm Injection: A Systematic Review. Cureus. 2025 Jun 13;17(6):e85959. doi: 10.7759/cureus.85959. eCollection 2025 Jun.
PubMed 40524846Zhang J, Du M, Li Z, Liu W, Ren B, Zhang Y, Guan Y. Comparison of Dydrogesterone and Medroxyprogesterone in the Progestin-Primed Ovarian Stimulation Protocol for Patients With Poor Ovarian Response. Front Endocrinol (Lausanne). 2021 Sep 24;12:708704. doi: 10.3389/fendo.2021.708704. eCollection 2021.
PubMed 34630325Yu S, Long H, Chang HY, Liu Y, Gao H, Zhu J, Quan X, Lyu Q, Kuang Y, Ai A. New application of dydrogesterone as a part of a progestin-primed ovarian stimulation protocol for IVF: a randomized controlled trial including 516 first IVF/ICSI cycles. Hum Reprod. 2018 Feb 1;33(2):229-237. doi: 10.1093/humrep/dex367.
PubMed 29300975
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of rFSH Alone Versus rFSH+rLH in Dydrogesterone-Based Progestin Protocol Cycles
- ClinicalTrials.gov ID
- NCT07348757
- Acronym / sponsor ID
- DYG-GONA / 2025-11
- Conditions
- InVitro Fertilization, Gonadotropins
- Keywords
- gonadotropins, invitro fertilization, pregnancy, ppos
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Centrum Clinic IVF CenterUniversity, hospital or other
- Study start
- 5 Feb 2026 (actual)
- Primary completion
- 15 Jun 2026 (actual)
- Study completion
- 20 Jun 2026 (actual)
- First posted
- 16 Jan 2026 (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.
This study aims to compare two commonly used hormone treatments for women undergoing IVF. All participants will receive a stimulation protocol that includes dydrogesterone, a medication used to safely control natural hormone surges during treatment. The study will observe women who are treated either with recombinant FSH alone or with a combination of recombinant FSH and recombinant LH-both routinely used options in our clinic.
Investigators will prospectively monitor how these treatments affect the growth of ovarian follicles, the number of mature eggs collected, the quality of developing embryos, and early pregnancy outcomes. No additional procedures or medications will be required beyond standard IVF care. The goal is to better understand whether adding recombinant LH provides any measurable benefit in dydrogesterone-based PPOS cycles.
Detailed description
This prospective observational study aims to evaluate how two routinely used gonadotropin strategies influence ovarian response and reproductive outcomes in women undergoing IVF treatment with a dydrogesterone-based Progestin-Primed Ovarian Stimulation (PPOS) protocol. In standard clinical practice, ovarian stimulation may be performed using recombinant FSH alone or a combination of recombinant FSH and recombinant LH. Both approaches are already used in daily care, and the choice of regimen is determined by the treating physician according to individual patient characteristics. The study does not assign treatments; instead, it observes and compares outcomes in patients receiving these medications as part of routine management.
Dydrogesterone is administered from Day 2 of the cycle to prevent premature LH surges, allowing controlled follicular growth. Participants will undergo regular ultrasound monitoring and bloodwork as part of their usual IVF treatment. When appropriate follicular maturation is achieved, final oocyte maturation will be triggered, followed by oocyte retrieval according to standard clinical protocols.
The primary focus of this study is to compare the number of mature (MII) oocytes obtained between the two gonadotropin regimens. Secondary outcomes include the number of good-quality blastocysts, implantation rate, and ongoing pregnancy rate, which together provide a comprehensive assessment of IVF success. Additional stimulation characteristics-such as follicle growth patterns, estradiol and LH levels, total gonadotropin dose, and duration of stimulation-will also be documented to explore differences in cycle dynamics.
No extra medications, procedures, or interventions will be required beyond routine IVF care. All data will be collected prospectively and analyzed to determine whether adding recombinant LH offers measurable clinical advantages compared with recombinant FSH alone in dydrogesterone-PPOS cycles.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant FSH Only Group | – | –Recombinant FSH (rFSH) Group - Additional Information Participants in this cohort will undergo ovarian stimulation using recombinant follicle-stimulating hormone (rFSH) alone, following routine IVF clinical practice. Dydrogesterone will be initiated on Cycle Day 2 as part of the standard PPOS (Progestin-Primed Ovarian Stimulation) protocol to prevent premature LH surge. Follicular development will be monitored with ultrasound and serum hormone levels, and the timing of final oocyte maturation and oocyte pick-up will follow standard clinical procedures. No additional medications or interventions will be administered beyond those routinely used for IVF treatment. |
| Recombinant FSH Plus Recombinant LH Group | – | –Recombinant FSH Plus Recombinant LH (2:1 Combination) Group - Additional Information Participants in this cohort will receive a combination of recombinant follicle-stimulating hormone (rFSH) and recombinant luteinizing hormone (rLH) in a fixed 2:1 ratio, as routinely used in clinical IVF practice. Dydrogesterone will be initiated on Cycle Day 2 according to the standard PPOS (Progestin-Primed Ovarian Stimulation) protocol to prevent premature LH surge. Follicular development will be monitored through ultrasound examinations and serum hormone measurements, and final oocyte maturation and oocyte retrieval will be performed following standard clinical procedures. No additional treatments or study-specific interventions will be administered beyond those normally used in IVF care. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants will be selected from women seeking infertility treatment at a fertility clinic and undergoing in-vitro fertilization (IVF) with controlled ovarian stimulation. This population typically consists of reproductive-age women who have difficulty achieving pregnancy and require assisted reproductive technologies. Eligible patients are generally healthy enough to undergo ovarian stimulation, have adequate ovarian reserve (AMH > 1 ng/mL), and meet age and BMI criteria for standard IVF care. Women in this group routinely receive dydrogesterone-based PPOS protocols as part of their clinical treatment, and the choice of gonadotropin regimen (rFSH alone or rFSH+rLH) follows routine medical practice. This population reflects real-world patients commonly treated in IVF programs
Key inclusion criteria (7 listed)
- Women aged 20 to 43 years.
- BMI < 30 kg/m².
- AMH > 1 ng/mL.
- Undergoing IVF/ICSI treatment with a dydrogesterone-based PPOS protocol.
- Women with regular menstrual cycles or clinically acceptable cycle pattern for stimulation.
Key exclusion criteria (9 listed)
- Cycle cancellation due to lack of viable embryos.
- Prior or planned PGT-A in the same cycle.
- Adenomyosis diagnosed by ultrasound or MRI.
- Uncorrected uterine anomalies (e.g., bicornuate, unicornuate, didelphys uterus).
- Presence of hydrosalpinx.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
numbers of top quality blastocysts
Time frame: day 5 after fertilization
Top-quality blastocysts are defined according to the Gardner and Schoolcraft blastocyst grading system as blastocysts with full expansion (grade ≥3), an inner cell mass (ICM) grade of A or B, and a trophectoderm (TE) grade of A or B (i.e., grades ≥3BB)
mature oocytes collected (MII)
Time frame: The overall assessment period spans the duration of ovarian stimulation and scheduling of oocyte aspiration, with a maximum observation period of up to 3-4 weeks
Time Frame: From the date of participant enrollment, including initiation of controlled ovarian stimulation, through the completion of the oocyte pick-up (OPU) procedure, with the number of mature (metaphase II) oocytes assessed and recorded exclusively at the time of oocyte aspiration. The overall assessment period spans the duration of ovarian stimulation and scheduling of OPU, with a maximum observation period of up to 3-4 weeks
3 secondary outcomes
total numbers of blastocysts
Time frame: From participant enrollment and initiation of ovarian stimulation through completion of embryo culture to the blastocyst stage, over a maximum period of up to 3-4 weeks.
Clinical pregnancy rate per embryo transfer
Time frame: 6-7 weeks after embryo transfer
Live birth rate per embryo transfer (LBR per ET)
Time frame: At delivery
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 23 Sep 2026.
- Background: PubMed 40524846Muharam R, Nurdya AN, Yo EC, Sumapraja K, Harzif AK, Maidarti M, Wiweko B, Hestiantoro A. Comparing Dydrogesterone Versus Medroxyprogesterone in Progestin-Primed Ovarian Stimulation (PPOS) for Patients Undergoing In Vitro Fertilization/Intracytoplasmic Sperm Injection: A Systematic Review. Cureus. 2025 Jun 13;17(6):e85959. doi: 10.7759/cureus.85959. eCollection 2025 Jun.
- Background: PubMed 34630325Zhang J, Du M, Li Z, Liu W, Ren B, Zhang Y, Guan Y. Comparison of Dydrogesterone and Medroxyprogesterone in the Progestin-Primed Ovarian Stimulation Protocol for Patients With Poor Ovarian Response. Front Endocrinol (Lausanne). 2021 Sep 24;12:708704. doi: 10.3389/fendo.2021.708704. eCollection 2021.
- Background: PubMed 29300975Yu S, Long H, Chang HY, Liu Y, Gao H, Zhu J, Quan X, Lyu Q, Kuang Y, Ai A. New application of dydrogesterone as a part of a progestin-primed ovarian stimulation protocol for IVF: a randomized controlled trial including 516 first IVF/ICSI cycles. Hum Reprod. 2018 Feb 1;33(2):229-237. doi: 10.1093/humrep/dex367.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involves sensitive reproductive health information and data are collected solely for clinical and research purposes within the center. Only aggregated, de-identified results will be reported in publications. Supporting Documents to Be Shared: None.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 InVitro Fertilization and Gonadotropins, run by Centrum Clinic IVF Center at 2 sites in Turkey (Türkiye).
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 7 inclusion and 9 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 23 Sep 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 Turkey (Türkiye). 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?
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?
numbers of top quality blastocysts (time frame: day 5 after fertilization). The study lists 2 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 NCT07348757, which also lists 3 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 23 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.