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NCT05939284·Not applicable·INTERVENTIONAL

Progesterone-Primed Ovarian Simulation in Controlled-ovarian Simulation of Infertile PCOS Patients

CetrorelixOtherCompleted

Status

Completed

Phase

Not applicable

Enrollment

238

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The study evaluated the safety and efficacy of the progesterone-primed ovarian stimulation (PPOS) coupled with gonadotropin (FSH) for infertile women with polycystic ovary syndrome (PCOS) who were assigned for ICSI and frozen blastocyst transfer. 200 infertile women were divided randomly into Group C, which received Cetrorelix injection (0.25 mg daily) on day-6, and Group S, which received oral dydrogesterone (20 mg/day) on day-2 of the menstrual cycle till the trigger day. All patients received an FSH injection of 225 IU daily from day-2 till triggering day. ICSI was performed and day-5 blastocysts underwent vitrification ultra-rapid cryopreservation till being transferred. Outcomes included the ability of PPOS to suppress the premature luteinizing hormone (LH) surge and prevent the development of ovarian hyperstimulation syndrome (OHSS), the incidence of profound LH suppression, the number of retrieved M2 oocyte and fertilization, chemical and clinical pregnancy rates, and the miscarriage rate.

Interventions

Treatment arms and agents.

DRUG

Injection of Cetrorelix

Patients received Cetrorelix subcutaneous injection on the day-6 in a dose of 0.25 daily till the trigger day.

DRUG

Oral insertion of dydrogeserone

Patients received dydrogesterone in an oral dose of 20 mg/day in parallel with gonadotropin injection from day-2 of the menstrual cycle till the trigger day

Timeline

From registration to results.

  1. First posted

    Jul 11, 2023

  2. Study start

    Jun 1, 2021

  3. Primary completion

    Sep 14, 2022

  4. Study completion

    Jan 25, 2023

  5. Results posted

    Not reported

  6. Registry updated

    Jul 11, 2023

Outcomes

What the study measures.

Primary outcomes

Success rate of PPOS in relation to Premature LH surge suppression

Time frame · 12 months

the success rate of PPOS as regards the suppression of premature LH surge and prevention of the development of OHSS.

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

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

Inclusion Criteria: * Infertile PCOS women; * aged 20-35 years; * had BMI \<35 kg/m2. Exclusion Criteria: * Women who were younger than 20 or older than 35 years, * obese of grade II or III, * had poor OR, other causes of infertility, * had previous attempts of IVF, had a history of repeated pregnancy loss.

Study locations

1 registered sites.

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

Zagazig university

Zagazig, Ash Sharqia Governorate, Egypt

Publications

Results and literature.

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

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Cetrorelix.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsCetrorelix trial dashboard →DatabaseCetrorelix database entry →ResearchCetrorelix research guide →