Half-dose vs Conventional-dose Cetrorelix in ICSI Cycles

September 22, 2026 updated by: Samar Ahmed Mohy Eldien, Assiut University

Half-dose Versus Conventional-dose Cetrorelix in Antagonist ICSI Cycles: Prospective Comparative Cohort Study

This prospective cohort study aims to compare the effectiveness of half-dose (0.125 mg/day) versus conventional-dose (0.25 mg/day) cetrorelix in GnRH antagonist ICSI cycles regarding clinical pregnancy rate in women with BMI ≥25 kg/m².

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Cetrorelix is used as a GnRH antagonist to prevent premature LH surge during controlled ovarian stimulation for ICSI. This observational study will include women aged less than 35 years with normal ovarian reserve and BMI ≥25 kg/m² who received either half-dose or conventional-dose cetrorelix as part of routine care. Clinical pregnancy rate and secondary reproductive outcomes will be compared between the two groups.

Study Type

Observational

Enrollment (Estimated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Samar A Mohy eldin, Resident
Phone Number: 01142926439
Email: samarmohy42@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 34 years (Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women aged less than 35 years with BMI ≥25 kg/m² and normal ovarian reserve who received either half-dose or conventional-dose cetrorelix as part of routine care during GnRH antagonist ICSI cycles at Assiut University Hospital.

Description

Inclusion Criteria:

- Age less than 35 years
Normal ovarian responders (AMH ≥1.2 ng/mL and AFC 5-15)
Body mass index (BMI) ≥25 kg/m²
Written informed consent

Exclusion Criteria:

- Age greater than 35 years
Diminished ovarian reserve (AMH <1.2 ng/mL or AFC <5)
Congenital uterine anomalies or significant intrauterine pathology
Contraindications to ovarian stimulation or pregnancy
Refusal to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: COHORT
Time Perspectives: PROSPECTIVE

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Half-dose Cetrorelix 0.125 mg Women who received cetrorelix 0.125 mg daily as part of routine GnRH antagonist protocol.
Conventional-dose Cetrorelix 0.25 mg Women who received cetrorelix 0.25 mg daily as part of routine GnRH antagonist protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Pregnancy Rate Time Frame: 6 weeks after embryo transfer	Proportion of women with intrauterine gestational sac with fetal heartbeat by ultrasound at 6 weeks gestation	6 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ongoing pregnancy rate Time Frame: 12 weeks after embryo transfer	Ongoing pregnancy with heartbeat >12 weeks on ultrasound	12 weeks after embryo transfer
Number of retrieved oocytes Time Frame: Periprocedurally, at time of oocyte retrieval, during oocyte pickup procedure	Mean number of oocytes retrieved at pickup	Periprocedurally, at time of oocyte retrieval, during oocyte pickup procedure
Number of mature MII oocytes Time Frame: Periprocedurally , at time of oocyte retrieval, Day 0, during oocyte pickup procedure	Mean number of mature MII oocytes	Periprocedurally , at time of oocyte retrieval, Day 0, during oocyte pickup procedure
Fertilization rate Time Frame: 1 day after ICSI	Fertilized oocytes / MII oocytes	1 day after ICSI
Premature LH surge Time Frame: Baseline (before hCG trigger)	LH >=10 IU/L or progesterone >=1.0 ng/mL before trigger	Baseline (before hCG trigger)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

Study Chair: Mohamed S Abdallah, prof, obstetrics and gynecology Department, Assiut University Hospitals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 20, 2026

Primary Completion (Estimated)

September 20, 2027

Study Completion (Estimated)

March 20, 2028

Study Registration Dates

First Submitted

September 17, 2026

First Submitted That Met QC Criteria

September 22, 2026

First Posted (Actual)

September 23, 2026

Study Record Updates

Last Update Posted (Actual)