GDF-8 Levels in ICSI Cycles

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Procedure: Long Gn-RH agonist protocol - Intracytoplasmic Sperm Injection

• Registration Number: NCT06529627
• Lead Sponsor: University of Alexandria

Brief Summary

The aim of this study is to investigate the role of GDF-8 in regulating progesterone levels during controlled ovarian stimulation in patients undergoing ICSI-ET and to evaluate its effects on pregnancy rates.

The main questions are

* Does serum GDF-8 correlate with serum Progesterone levels during ovarian stimulation?

* Does serum GDF-8 serum level at different time-points during ovarian stimulation correlate with pregnancy rate?

participants will undergo ICSI-ET cycle using the long GnRH-agonist protocol and serum levels of GDF-8 and progesterone will be measured at three time-points during the trial: on day of hCG trigger administration, on day of oocyte pickup, and 14 days after embryo transfer

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-01
• Primary Completion: 2023-12-15
• Study Completion: 2024-01-31
• Status Verified: 2024-07
• Study First Submitted: 2024-07-26
• Study First Submitted QC: 2024-07-30
• Last Update Submitted: 2024-07-30
• Study First Posted: 2024-07-31
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 42

Inclusion Criteria

• The study population included women who underwent their first ICSI-ET cycles due to male and/or tubal factors or unexplained infertility, aged 20-35 years, whose BMI ranged from 19-29.9 kg/m2, with regular menstrual cycles

Exclusion Criteria

• women with PCOS, couples with azoospermic husbands, women with poor ovarian reserve testing (AMH < 1.2 ng/dl and/or AFC < 5), women diagnosed with endometriosis, and women with medical comorbidities such as thyroid disorders, DM, hyperprolactinemia, etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Long agonist protocol - ICSI-ET	Long Gn-RH agonist protocol - Intracytoplasmic Sperm Injection	-

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy	5 weeks after embryo transfer	visualization of intra-uterine gestational sac with a pulsating fetal pole within 5 weeks of embryo transfer
Serum Growth Differentiation Factor - 8 (GDF-8)	three time-points: on day of trigger, on day of OPU, and 14 days after ET	serum levels of GDF-8

Trial Locations

Locations (1)

Shatby maternity university hospital; 🇪🇬 Alexandria, Egypt