Growth Hormone and Dehydroepiandrosterone Role in Vitro Fertilization

NCT ID: NCT07323329

Last Updated: 2026-01-07

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

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-10

Study Completion Date

2026-11-12

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility Infertility (IVF Patients)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Somatropin group

Somatropin (4IU for 1 month) 1 S.C injection every 3 days for at least 1 month plus, folic acid 400mcg/day

Group Type EXPERIMENTAL

Somatropin (4IU for 1 month) plus, folic acid 400 mcg per day.

Intervention Type DRUG

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.

dehydroepiandrosterone

dehydroepiandrosterone 50 mg twice per day for 12 weeks plus folic acid 400mcg per day

Group Type EXPERIMENTAL

DHEA plus folic acid 400mcg per day

Intervention Type DRUG

Patients will receive DHEA 50 mg twice per day for 12 weeks plus folic acid 400mcg per day

Standard care

Patients will receive standard care will receive folic acid 400 mcg per day

Group Type ACTIVE_COMPARATOR

control group

Intervention Type DIETARY_SUPPLEMENT

Patients will receive folic acid 400 mcg per day

Interventions

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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.

Intervention Type 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

Intervention Type DRUG

control group

Patients will receive folic acid 400 mcg per day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beni-Suef University

OTHER

Sponsor Role lead

Responsible Party

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Hasnaa Osama

Lecturer of Clinical Pharmacy, Beni-Suef University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beni-Suef University Hospital

Banī Suwayf, Beni Suweif Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Marwa O. Elgendy, Associate professor

Role: primary

00201021941935

References

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Casson PR, Lindsay MS, Pisarska MD, Carson SA, Buster JE. Dehydroepiandrosterone supplementation augments ovarian stimulation in poor responders: a case series. Hum Reprod. 2000 Oct;15(10):2129-32. doi: 10.1093/humrep/15.10.2129.

Reference Type BACKGROUND
PMID: 11006185 (View on PubMed)

Related Links

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Other Identifiers

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FMBSUREC/01092024/Ragab

Identifier Type: -

Identifier Source: org_study_id

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