GDF-8 Levels in ICSI Cycles

NCT06529627 — Not applicable, Completed, 42 participants, University of Alexandria

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT06529627
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	42 (Actual)
Sponsor	University of Alexandria (Other)
Conditions	Infertility
Interventions	Long Gn-RH agonist protocol - Intracytoplasmic Sperm Injection (Procedure)
Dates	start 2023-05-01, primary completion 2023-12-15, completion 2024-01-31, first posted 2024-07-31, last updated 2024-07-31
Locations	1 site in Egypt

-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

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Long agonist protocol - ICSI-ET	Active comparator	Procedure: Long Gn-RH agonist protocol - Intracytoplasmic Sperm Injection

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

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: Female, ages: 20 Years to 35 Years

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)

Facility	City	Country	Status
Shatby maternity university hospital	Alexandria	Egypt