Progesterone Primed Ovarian Stimulation Versus GnRH Antagonist in With Expected High Ovarian Response Undergoing in Vitro Fertilization

NCT ID: NCT05951400

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-20
• Study Completion Date: 2023-09-30

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.

Conditions

IVF; PCO

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dydrogestrone

For pituitary suppression, the patients will receive either Dydrogestrone (Duphaston 20 mg/d; Abbott Healthcare, USA) orally starting at day 2-3

Group Type: EXPERIMENTAL

Dydrogesterone Tablets

Intervention Type: DRUG

used for pituitary suppression in ICSI cycle

GnRH antagonist

For pituitary suppression, the patients will receive GnRH antagonist Cetrorelix (CETROTIDE 0.25Mg/d, Merck Serono, Germany) 0.25 mg/day subcutaneously from day 6 of induction until trigger day.

Group Type: ACTIVE_COMPARATOR

Cetrorelix

Intervention Type: DRUG

GnRH antagonist for pituitary suppression

Interventions

Dydrogesterone Tablets

used for pituitary suppression in ICSI cycle

Intervention Type: DRUG

Cetrorelix

GnRH antagonist for pituitary suppression

Intervention Type: DRUG

Other Intervention Names

Duphaston; cetrotide

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Sara Abdallah Mohamed Salem

Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Beni-Suef University

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine Beni-Suef University

Locations

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, Egypt

Countries

Egypt

Central Contacts

Sara A Salem, MD

Role: CONTACT

sara_abdallah100@yahoo.com

01272842226 ext. 02

Other Identifiers

duphaston in ICSI for PCO

Identifier Type: -

Identifier Source: org_study_id