Gonadotropins, InVitro Fertilization
Conditions
Keywords
gonadotropins, invitro fertilization, pregnancy, ppos
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.
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.
Interventions
None listed
Sponsors
Centrum Clinic IVF Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mature oocytes collected (MII) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| numbers of top quality blastocysts | 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) |
| Clinical pregnancy rate per embryo transfer | 6-7 weeks after 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: % |
| Live birth rate per embryo transfer (LBR per ET) | At delivery | 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 |
Countries
Turkey (Türkiye)
Outcome results
None listed