GDF-8 Levels in ICSI Cycles

University of Alexandria42 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Infertility

Interventions

Long Gn-RH agonist protocol - Intracytoplasmic Sperm InjectionPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 35 Years

Medical Language ↔ Plain English

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.

Locations (1)

Shatby maternity university hospital

Alexandria, Egypt

Outcomes

Primary Outcomes

Clinical pregnancy

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

Time frame: 5 weeks after embryo transfer

Serum Growth Differentiation Factor - 8 (GDF-8)

serum levels of GDF-8

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

Data from ClinicalTrials.gov

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