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GDF-8 Levels in ICSI Cycles

U

University of Alexandria

Status

Completed

Conditions

Infertility

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06529627
0107574

Details and patient eligibility

About

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

Enrollment

42 patients

Sex

Female

Ages

20 to 35 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

42 participants in 1 patient group

Long agonist protocol - ICSI-ET
Active Comparator group
Treatment:
Procedure: Long Gn-RH agonist protocol - Intracytoplasmic Sperm Injection

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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