Clinical trial NCT05951400: Progesterone Primed Ovarian Stimulation Versus GnRH Antagonist in With Expected High Ovarian Response Undergoing in Vitro Fertilization
Official title: Progesterone Primed Ovarian Stimulation Protocol (PPOS) VS GnRH Antagonist Protocol in Patients With Expected High Ovarian Response Undergoing ICSI Cycles: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: IVF
PCO
Keywords: Cetrorelix
Dydrogesterone
GnRh antagonist
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effectiveness and safety of Progesterone Primed Ovarian Stimulation protocol (PPOS) using Dydrogestrone vs GnRH Antagonist Protocol in patients with expected high ovarian response undergoing ICSI cycle

Detailed description: Each patient will be subjected to:

Full history taking. Systematic clinical examination to assess the general condition, body mass index (BMI) and local pelvic physical findings and AFC by trans-vaginal ultrasound on D2 to 3 of menstruation.

Routine labs as CBC, liver \& kidney functions to exclude general disease as a contraindication for induction or pregnancy.

Blood sample will be obtained for assessment of basal serum levels of FSH, LH, E2 on days 2- 3 of the cycle. PRL, AMH and TSH Ovarian Stimulation The patients will begin injections of recombinant FSH (rFSH, Gonal-F; Merck-Serono, Italy) from day 2-3 of menstruation, with daily dose of 150-300 IU adjusted according to individual conditions on the basis of the antral follicle count (AFC),hormonal profile, age, body mass index (BMI), and previous ovarian response, according to the standard operating procedures of the center. .

For pituitary suppression, the patients will receive either Dydrogestrone (Duphaston 20 mg/d; Abbott Healthcare, USA) orally starting at day 2-3 or GnRH antagonist Cetrorelix (CETROTIDE 0.25Mg/d, Merck Serono, Germany) 0.25 mg/day subcutaneously from day 6 of induction until trigger day.

The serum LH, estradiol levels as well as number and size of follicles will be monitored every two days, starting from stimulation day 6 until the day of hCG injection. When most of dominant follicles reach diameter of 18-22 mm, the final oocyte maturation will be induced with 0.2 mg of Triptorelin (2 amp of Decapeptyl 0.1 mg, Ferring Pharmaceuticals, the Netherlands) (agonist trigger). Then, oocyte retrieval will be performed 34-36 h later with freezing of all embryos.

Frozen Embryo Transfer A maximum of 2 embryos will be transferred after endometrial preparation using Estradiol valerate(cycloprogenova 2mg tab Bayer Pharma AG, Germany) frome day 2 of cycle until endometrial thickness of 8 mm or more then adding progesterone 400 mg(Prontogest 400 IBSA pharmaceutical Italy) vaginal supp twice daily for 5 days and frozen embryo transfer will be on day 5 Transfer will be done by an expert using the same type of ET catheter under ultrasound guidance Adding progesterone 100 mg IM injection every other day if serum progesterone after 1st 4 doses of vag. Prog. is less than 9.2 ng/ml

An infant born alive after 22 weeks gestation was classified as a live birth. Clinical pregnancy is defined as the presence of at least 1 gestational sac on ultrasound at 6 weeks. Ongoing pregnancy is the presence of at least 1 fetus with heart pulsation on ultrasound beyond 10 weeks. Miscarriage rate was defined as the number of miscarriages before 24 weeks divided by the number of women with clinical pregnancy. Cancellation rate is defined as the number of patients with no viable embryos to transfer divided by the number of patients that started ovarian stimulation.

Eligibility criteria: Inclusion Criteria:

1. undergoing trial of ICSI.
2. BMI ≤ 30
3. AMH ≥3.5
4. AFC ≥ 20

Exclusion Criteria:

1. Any known contraindications to the approved fertility drugs.
2. Severe endometriosis.
3. Uterine malformations or abnormal uterine cavity.
4. Uncontrolled endocrinopathies:DM,hyperthyroidism, hypothyroidism
5. Severe male factor
6. History of recurrent ICSI failure or recurrent miscarriage

Primary outcomes:
measure: oocytes retrieved
timeFrame: 1 month of induction for ICSI trial
Secondary outcomes:
measure: Duration of stimulation days.
timeFrame: 1 month
measure: chemical pregnancy rate
timeFrame: 1 month
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef university Hospital
state: Beni Suef
Study officials:
affiliation: Faculty of Medicine Beni-Suef University
name: Beni-Suef University
role: PRINCIPAL_INVESTIGATOR
References: