CClinicalTrials.gg
CompletedNCT06529627Updated Jul 31, 2024

GDF-8 Levels in ICSI Cycles

An interventional study of Long Gn-RH agonist protocol - Intracytoplasmic Sperm Injection in Infertility, sponsored by University of Alexandria. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 35 Years. Per ClinicalTrials.gov, last updated 2024-07-31.

Sponsored by University of Alexandria · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled May 2023, registered Jul 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
20 Years to 35 Years
Sex
Female
01

Study 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

02

Conditions studied

  • Infertility

Browse trials for

03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 42 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

University of Alexandria is the lead sponsor of 57 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 35 Years
Sexes eligible
Female
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Active comparator
    Long agonist protocol - ICSI-ET

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

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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

07

Study locations

1 site
  • Shatby maternity university hospital
    Alexandria, 03312, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06529627
Lead sponsor
University of Alexandria
Responsible party
Mervat Sheikhelarab Elsedeek Ibrahim Omran (Professor of Obstetrics and Gynaecology, University of Alexandria) — Principal investigator
First posted
Jul 31, 2024
Start date
May 1, 2023
Primary completion
Dec 15, 2023
Completion
Jan 31, 2024
Last update
Jul 31, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion