Clinical trial NCT06868576: PPOS Protocol Versus GnRH Anatagonist for Expected Normal Responder Patients Undergoing ART : a Randomized Clinical Trial
Official title: Progestin-Primed Ovarian Stimulation Versus Gonadotrophin-Releasing Hormone Antagonist for Patients Undergoing Assisted Reproductive Technology: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: PPOS
GnRH Antagonist
Assisted Reproductive Techniques
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2025-03-11
Enrollment: 328
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: clinical pregnancy
timeFrame: 7 weeks of gestational age
Secondary outcomes:
measure: Incidence of moderate/severe OHSS
timeFrame: before triggering injection and within 9 days after triggering injection
measure: Number of metaphase 2 oocytes
timeFrame: within 1 day of ovum pick up
measure: number of 2 PN embryos
timeFrame: within 1 day of ovum pick up
measure: Biochemical pregnancy
timeFrame: 2-3 weeks after embryo transfer
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ciro University Kasr Alainy OBGYN Hospital
state: Alquahira
Study officials:
References: