Infertility
Conditions
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
Interventions
PROCEDURELong Gn-RH agonist protocol - Intracytoplasmic Sperm Injection
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
Sponsors
University of Alexandria
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single group of infertile couple undergoing ICSI-ET with the standard long GnRH agonist protocol
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed