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NCT Number: NCT07836400

Half-dose vs Conventional-dose Cetrorelix in ICSI Cycles

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.

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Key information

Conditions

Infertility Adnexal Diseases Anovulation Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Infertility, Female Ovarian Diseases Urogenital Diseases

Age range

18 year–34 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Ongoing pregnancy rate

    Time frame: 12 weeks after embryo transfer

    Ongoing pregnancy with heartbeat >12 weeks on ultrasound

  2. Number of retrieved oocytes

    Time frame: Periprocedurally, at time of oocyte retrieval, during oocyte pickup procedure

    Mean number of oocytes retrieved at pickup

  3. 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

  4. Fertilization rate

    Time frame: 1 day after ICSI

    Fertilized oocytes / MII oocytes

  5. Premature LH surge

    Time frame: Baseline (before hCG trigger)

    LH >=10 IU/L or progesterone >=1.0 ng/mL before trigger

Study contacts

Contact information is provided by the study sponsor or research team.

Samar A Mohy eldin, Resident

CONTACT

[email protected]

01142926439

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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