Progestin Primed Double Stimulation Protocol Versus Flexible GnRH Antagonist Protocol in Poor Responders
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Intervention: Duphaston; Gonadotropin; Cetrotide Injectable Product; Decapeptyl; Chorionic Gonadotropin; Combined Oral Contraceptive; Cyclo-Progynova; progesterone
Intervention description: will be used for pituitary suppression in the first arm:20 mg/day will be started from the first day of the ovulation induction in the follicular phase and in the luteal phase will be started the next day after oocyte pickup at 20 mg/day.; will be used for controlled ovarian hyperstimulation in both arms; will used in the second arm for pituitary suppression in the second group daily when the biggest oocyte reaches size 14 mm till ovulation triggering; will be used for ovulation triggering.in the first arm:in a dose of 2 ampules of 0.2 mg will be administered when leading follicle >18 mm in diameter. in the second arm:in a dose of 2 ampules 0.2 mg will be administered when leading follicle >18 mm in diameter in the first cycle only.; will be used in the second cycle of the second arm for ovulation triggering in a dose of 10,000 IU when the leading follicle >18 mm in diameter.; luteal phase priming from day 21 of the cycle before controlled ovarian stimulation for one week .; Starting from cycle Day 3 of the intented cycle for thawed embryo transfer, patients will receive the white tablets of Cyclo-Progynova daily. From Day 10 onwards, endometrium growth will be monitored by transvaginal ultrasound.; in the intended cycle of embryo transfer when endometrial thickness ≥ 7 mm. Progesterone administration (as 800 mg/day vaginal suppositories per day and 100 mg ampule IM every other day) will be continued until pregnancy testing 18 days after embryo transfer and in pregnant cases will continued till the 12 weeks of gestation.
Intervention MeSH terms: Triptorelin Pamoate; Contraceptive Agents; Contraceptives, Oral; Chorionic Gonadotropin; Cetrorelix; Contraceptives, Oral, Combined; Progesterone; Dydrogesterone; Estradiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 90.0
Sex: Female
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

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. Poor ovarian
      responders (PORs) involve 9-24% of patients undergoing in-vitro fertilization (IVF). proper
      tailoring of the ovarian stimulation protocol in order 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 coincides 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, clinicians have been attempting to retrieve oocytes from poor
      responders using both the follicular-phase stimulation (FPS) and the luteal-phase stimulation
      (LPS) protocols to increase the number of oocytes collected shorter within shorter period of
      time. By increasing the number of the retrieved oocytes collected, a better clinical can be
      assured 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.
    

Eligibility criteria:

        Inclusion Criteria:

        poor ovarian responders patients defined by Bologna criteria

        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.