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

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.

Conditions

• Infertility, Female

Interventions

DRUG

Duphaston

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.

DRUG

Gonadotropin

will be used for controlled ovarian hyperstimulation in both arms

DRUG

Cetrotide Injectable Product

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

DRUG

Decapeptyl

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.

DRUG

Chorionic Gonadotropin

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.

DRUG

Combined Oral Contraceptive

luteal phase priming from day 21 of the cycle before controlled ovarian stimulation for one week .

DRUG

Cyclo-Progynova

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.

DRUG

progesterone

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.

Sponsors & Collaborators

• El Shatby University Hospital for Obstetrics and Gynecology

  lead OTHER

Principal Investigators

• Aly A Hussein, Ass.lecturer · Elshatby University hospital

• Sherif S Gaafar, Professor · Elshatby University hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-09-01

Primary Completion

2021-03-01

Completion

2021-09-01

FDA Drug

Yes

Countries

• Egypt

Study Locations