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NCT Number: NCT07323329

Growth Hormone and Dehydroepiandrosterone Role 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.

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Key information

Conditions

Infertility Genital Diseases Infertility (IVF Patients) Urogenital Diseases

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Beni-Suef University Hospital

Banī Suwayf, Beni Suweif Governorate, 62521, Egypt

Location status: Recruiting

Location contact

Marwa O. Elgendy, Associate professor

CONTACT

[email protected]

00201021941935

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

  • Advanced maternal age (>40 years) or any other risk factor for Poor Ovarian Response (POR).
  • ≤3 oocytes with a conventional stimulation protocol).
  • 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

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

Treatment and study plan

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

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.

DHEA plus folic acid 400mcg per day

Drug

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

Control group

Dietary Supplement

Patients will receive folic acid 400 mcg per day

Primary outcomes

  1. The number of mature oocyte

    Time frame: 12 weeks

Secondary outcomes

  1. pregnancy rate

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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