rFSH vs rFSH+rLH in Dydrogesterone-Based Progestin Protocol: A Prospective Study (DYG-GONA)

Centrum Clinic IVF Center

Status: Enrolling

Conditions: InVitro Fertilization; Gonadotropins

Study type: Observational

Funder types: Other

Identifiers

NCT07348757

2025-11

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

300 participants in 2 patient groups

Recombinant FSH Only Group

Description:

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

Description:

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.