Growth Hormone and Dehydroepiandrosterone Role in Vitro Fertilization

December 31, 2025 updated by: Hasnaa Osama, Beni-Suef University

Growth Hormone and Dehydroepiandrosterone Effect on Poor Ovarian Reserve Patients During in Vitro Fertilization

The goal of this study is to evaluate the role of Somatropin and Dehydroepiandrosterone (DHEA) on ovarian reserve parameters and intracytoplasmic sperm injection (ICSI) outcome in poor ovarian responder.

The main question it aims to answer is:

Which intervention is more effective in increasing number and size of follicles? Participants will be followed 1 month before starting induction in growth hormone and 12 weeks for DHEA and through intracytoplasmic sperm injection (ICSI) cycle.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

165

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Beni Suweif Governorate
      • Banī Suwayf, Beni Suweif Governorate, Egypt, 62521
        • Recruiting
        • Beni-suef university Hospital
        • Contact:
          • Marwa O. Elgendy, Associate professor
          • Phone Number: 00201021941935
          • Email: amal.emam@yahoo.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

At least two of the following three criteria had to be present after maximal stimulation:

  1. Advanced maternal age (>40 years) or any other risk factor for Poor Ovarian Response (POR).
  2. ≤3 oocytes with a conventional stimulation protocol).
  3. An abnormal ovarian reserve test [i.e. antral follicle count (AFC) less than 5-7 follicles or anti-Müllerian hormone (AMH) below 0.5-1.1 ng/ml].

Exclusion Criteria:

  1. Any endocrine or metabolic disorder such as hyperprolactinemia, diabetes and thyroid dysfunction.
  2. Any pelvic pathology such as hydrosalpinx, uterine anomaly.
  3. Any male factor infertility such as Oligo-Astheno-Teratozoospermia (OAT) or azoospermia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Somatropin group
Somatropin (4IU for 1 month) 1 S.C injection every 3 days for at least 1 month plus, folic acid 400mcg/day
Drug: Somatropin (4IU for 1 month) plus, folic acid 400 mcg per day.
Patients will receive Somatropin (4IU for 1 month)1 S.C injection every 3 days for at least 1 month plus, folic acid 400 mcg per day.
Experimental: dehydroepiandrosterone
dehydroepiandrosterone 50 mg twice per day for 12 weeks plus folic acid 400mcg per day
Drug: DHEA plus folic acid 400mcg per day
Patients will receive DHEA 50 mg twice per day for 12 weeks plus folic acid 400mcg per day
Active Comparator: Standard care
Patients will receive standard care will receive folic acid 400 mcg per day
Dietary supplement: control group
Patients will receive folic acid 400 mcg per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of mature oocyte
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
pregnancy rate
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2025

Primary Completion (Estimated)

October 15, 2026

Study Completion (Estimated)

November 12, 2026

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

December 31, 2025

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

December 31, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMBSUREC/01092024/Ragab

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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