rFSH vs rFSH+rLH in Dydrogesterone-Based Progestin Protocol: A Prospective Study

NCT07348757 | Recruiting

• 1 other identifier: 2025-11
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

InVitro Fertilization; Gonadotropins

Keywords

gonadotropins; invitro fertilization; pregnancy; ppos

Outcome Measures

Primary Outcomes (1)

• 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

  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 (4)

• total numbers of blastocysts

  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.

• numbers of top quality blastocysts

  Day 5 after fertilization

• Clinical pregnancy rate per embryo transfer

  6-7 weeks after embryo transfer

• Live birth rate per embryo transfer (LBR per ET)

  At delivery

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• 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.
• Refusal or inability to provide informed consent.
• Severe systemic disease or contraindication to ovarian stimulation.
• Prior bilateral oophorectomy

Sponsors & Collaborators

• Centrum Clinic IVF Center: lead

Study Sites (2)

Centrum Clinic IVF Center

Ankara, Ankara, 06800, Turkey (Türkiye)

RECRUITING

Bahçeci IVF Center

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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.

  PMID: 40524846 BACKGROUND

• Zhang 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.

  PMID: 34630325 BACKGROUND

• Yu 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.

  PMID: 29300975 BACKGROUND

Central Study Contacts

Emre G pabuçcu, Professor

CONTACT

+905324147844; emregpabuccu@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: January 16, 2026
• Study Start: January 5, 2026
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 10, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)