Comparison of rFSH Alone Versus rFSH+rLH in Dydrogesterone-Based Progestin Protocol Cycles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 2
- 主要终点
- mature oocytes collected (MII)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
结局指标
主要结局
mature oocytes collected (MII)
时间窗: 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
次要结局
- 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)
研究者
Emre Göksan Pabuçcu
Prof. Dr.
Centrum Clinic IVF Center