Current partner codePEPTIDESDE

Progesterone Primed Protocol Versus GnRH Antagonist in With PCO Undergoing ICSI

Status

Completed

Phase

Phase 2 / Phase 3

Enrollment

200

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Full 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 (Duphaston30mg/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. 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) 4mg 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.

Interventions

Treatment arms and agents.

DRUG

Dydrogesterone Tablets

used for pituitary suppression in ICSI cycle

DRUG

Cetrorelix

GnRH antagonist for pituitary suppression

Timeline

From registration to results.

  1. First posted

    Jul 19, 2023

  2. Study start

    Jan 1, 2024

  3. Primary completion

    Mar 30, 2026

  4. Study completion

    Apr 5, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Apr 15, 2026

Outcomes

What the study measures.

Primary outcomes

oocytes retrieved

Time frame · 1 month of induction for ICSI trial

Number of oocytes retrieved classified

Secondary outcomes

Duration of stimulation days.

Time frame · 1 month

number of days till giving trigger

chemical pregnancy rate

Time frame · 1 month

number of pregnancy test positive

Eligibility

Who can take part.

Minimum age
20 Years
Maximum age
40 Years
Sex
FEMALE
Healthy volunteers
No

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

Study locations

1 registered sites.

Egypt. Showing up to 24 locations stored in the fast local snapshot.

Beni-suef university Hospital

Banī Suwayf, Beni Suweif Governorate, Egypt

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Cetrorelix.

Related PeptideStat pages

Put the record in context.

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