GDF-8 Levels in ICSI Cycles

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

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Shatby maternity university hospital

Alexandria, 03312, Egypt

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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

Primary outcomes

Clinical pregnancy

Time frame: 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)

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

serum levels of GDF-8

Sponsors and collaborators

Lead sponsor

University of Alexandria

Other

Registry information

Official study title

Effect of Growth Differentiation Factor - 8 (GDF-8) on Pregnancy Rates in GnRH-agonist ICSI Cycles: A Prospective Cohort Study

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2024
First posted: Jul 31, 2024
Registry last updated: Jul 31, 2024

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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Completed