Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

The worldwide prevalence of primary and secondary infertility is estimated at ~2% and 10.5%, respectively, among women aged 20-44 years and attempting to conceive. These women may enter an IVF program and be classified as poor prognosis patients for several distinct causes (e.g. advanced maternal age, low ovarian reserve). proper tailoring of the ovarian stimulation protocol to maximize the number of oocytes collected represents a crucial step for them to eventually conceive .

Recent evidence indicates that in the same menstrual cycle, there are multiple follicular recruitment waves. This is in accord with the theory that folliculogenesis occurs in a wave-like fashion. Thus, within a single menstrual cycle, there can theoretically be multiple opportunities for a clinician to collect oocytes, as opposed to the conventional single cohort of antral follicles during the follicular phase .

Utilizing this concept, reproductive endocrinologists have been attempting to retrieve oocytes from poor responders using both the follicular-phase stimulation (FPS) and the luteal-phase stimulation (LPS) protocols in order to increase the number of oocytes collected shorter period of time. The number of oocytes collected in IVF is a robust surrogate outcome for clinical success since there is a clear relationship between the number of oocytes collected and live birth rates across all female age groups.

which protocol is the most effective remains controversial and the efficacy of PPOS in POR compared with that of conventional protocols is unclear.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: El Shatby University Hospital for Obstetrics and Gynecology
• Treatments: Cetrorelix; Chorionic Gonadotropin; Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined; Dydrogesterone; Estradiol; Progesterone; Triptorelin Pamoate

Criteria

Inclusion Criteria:

• 1. Indicated infertile women for ICSI of poor responders defined by Bologna criteria either two or more of the following:(15) (i) advanced maternal age or any other risk factor for POR. (ii) a previous POR ; less than 3-5 oocytes retrieved per cycle. (iii) an abnormal ovarian reserve test (ORT): AFC less than 5-7 or AMH is less than 1.1 ng/ml.

Or two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder in the absence of advanced maternal age or abnormal ORT.

Exclusion Criteria:

1. Male factor infertility due to azoospermia. 2. Patients with uncorrected uterine pathology. 3. Patients with the diagnosis of severe endometriosis. 4. Patients with BMI over 35.

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