GDF-8 Levels in ICSI Cycles

NCT06529627 | Completed

• 1 other identifier: 0107574
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Conditions

Infertility

Outcome Measures

Primary Outcomes (2)

• Clinical pregnancy

  visualization of intra-uterine gestational sac with a pulsating fetal pole within 5 weeks of embryo transfer

  5 weeks after embryo transfer

• Serum Growth Differentiation Factor - 8 (GDF-8)

  serum levels of GDF-8

  three time-points: on day of trigger, on day of OPU, and 14 days after ET

Study Arms (1)

Long agonist protocol - ICSI-ET

ACTIVE COMPARATOR

Procedure: Long Gn-RH agonist protocol - Intracytoplasmic Sperm Injection

Interventions

Long Gn-RH agonist protocol - Intracytoplasmic Sperm Injection PROCEDURE

pituitary downregulation with GnRH agonist - ovarian stimulation with exogenous gonadotropin - hCG adminstration as trigger of oocyte maturation Oocyte retriveal via transvaginal ultrasound guided aspiration embryo transfer progesterone as luteal phase support

Long agonist protocol - ICSI-ET

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alexandria: lead

Study Sites (1)

Shatby maternity university hospital

Alexandria, 03312, Egypt

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Obstetrics and Gynaecology

Model Details: Single group of infertile couple undergoing ICSI-ET with the standard long GnRH agonist protocol

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 31, 2024
• Study Start: May 1, 2023
• Primary Completion: December 15, 2023
• Study Completion: January 31, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)