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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients that will undergo progestin primed ovarian stimulation (PPOS) protocol using dydrogesterone | Experimental |
| |
| patients that will receive the conventional GnRH antagonist. | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dydrogesterone Oral Tablet | Drug | Dydrogesterone 20mg tablets daily in PPOS protocol in ovarian stimulation starting from day 2 or 3 of the menstrual cycle until the triggering day |
| Measure | Description | Time Frame |
|---|---|---|
| clinical pregnancy | The presence of fetal pulsations by ultrasound at 7 weeks of gestational age | 7 weeks of gestational age |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
• Women who had history of infertility for ≥1 year.
Exclusion Criteria:
• Age ≥ 40 years old.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ciro University Kasr Alainy OBGYN Hospital | Cairo | Alquahira | 11835 | Egypt |
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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.
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| Cetrorelix (Cetrotide) | Drug | This will be the conventional antagonist in ovarian stimulation given from day 6 of the menstrual cycle until the triggering day |
|
| number of 2 PN embryos |
| within 1 day of ovum pick up |
| Biochemical pregnancy | Quantitative Beta chorinioic gonadotrophin (B-HCG) hormone levels in blood 2 to 3 weeks after embryo transfer. | 2-3 weeks after embryo transfer |
| ID | Term |
|---|---|
| D004394 | Dydrogesterone |
| C062876 | cetrorelix |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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