Assisted Reproductive Techniques, GnRH Antagonist, PPOS
Conditions
Brief summary
The aim of this study is to compare the efficacy and safety of Progestin-Primed Ovarian Stimulation (PPOS) protocol versus the fixed GnRH antagonist protocol in expected normal responder patients undergoing intracytoplasmic sperm injection (ICSI) with frozen-thawed embryo transfer (FET). By evaluating key clinical outcomes, including ovarian response, embryological parameters, and pregnancy rates, this study seeks to determine the relative advantages and limitations of each protocol.
Detailed description
In this prospective, non-inferiority trial, we will compare the efficacy and safety of the GnRH antagonist and PPOS protocols in 328 infertile women undergoing ICSI in Kasr Al-Ainy IVF department, Cairo University, Egypt. Before the trial, investigators were required to provide all information related to the clinical trial, including the possible benefits and risks, other therapeutic choices and the right to withdraw, via a written consent. After being provided with sufficient time to decide whether to participate and the opportunity to ask questions, all participants were required to provide written informed consent before study inclusion.
Interventions
Dydrogesterone 20mg tablets daily in PPOS protocol in ovarian stimulation starting from day 2 or 3 of the menstrual cycle until the triggering day
This will be the conventional antagonist in ovarian stimulation given from day 6 of the menstrual cycle until the triggering day
Sponsors
Kasr El Aini Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Three hundred twenty-eight women will be divided into 2 groups (A and B), each group will consist of 164 patients: \*Group A (Study group): Includes 164 patients that will undergo progestin primed ovarian stimulation (PPOS) protocol using dydrogesterone. \*Group B (control group): Includes 164 patients that will receive the conventional GnRH antagonist.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
No
Inclusion criteria
* • Women who had history of infertility for ≥1 year. * Women whose age \<40 years old by the end of the study. * Anti-Mullerian hormone \> 1.2 ng/ml. * Antral follicle count ≥ 5.
Exclusion criteria
* • Age ≥ 40 years old. * Women who are diagnosed as polycystic ovarian syndrome. * Women with endometriosis stage 3 or 4. * Documented previous IVF/ICSI cycles with no oocytes retrieved. * Women with contraindications to controlled ovarian stimulation. * Patients who refuse to share in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical pregnancy | 7 weeks of gestational age | The presence of fetal pulsations by ultrasound at 7 weeks of gestational age |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of moderate/severe OHSS | before triggering injection and within 9 days after triggering injection | — |
| Number of metaphase 2 oocytes | within 1 day of ovum pick up | — |
| number of 2 PN embryos | within 1 day of ovum pick up | — |
| Biochemical pregnancy | 2-3 weeks after embryo transfer | Quantitative Beta chorinioic gonadotrophin (B-HCG) hormone levels in blood 2 to 3 weeks after embryo transfer. |
Countries
Egypt
Outcome results
None listed