GDF-8 Levels in ICSI Cycles

NCT ID: NCT06529627

Last Updated: 2024-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-01

Study Completion Date

2024-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group of infertile couple undergoing ICSI-ET with the standard long GnRH agonist protocol
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Long agonist protocol - ICSI-ET

Group Type ACTIVE_COMPARATOR

Long Gn-RH agonist protocol - Intracytoplasmic Sperm Injection

Intervention Type 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

Interventions

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Long 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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Alexandria

OTHER

Sponsor Role lead

Responsible Party

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Mervat Sheikhelarab Elsedeek Ibrahim Omran

Professor of Obstetrics and Gynaecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shatby maternity university hospital

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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0107574

Identifier Type: -

Identifier Source: org_study_id

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