Growth hormone versus DHEA to boost follicle response in IVF for poor ovarian responders

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

This trial will test whether adding growth hormone or DHEA helps women with poor ovarian reserve produce more and larger follicles during ICSI.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 165 (estimated)
• Ages: 18 Years to 35 Years
• Sex: Female
• Sponsor: Beni-Suef University (other)
• Locations: 1 site (Banī Suwayf, Beni Suweif Governorate)
• Trial ID: NCT07323329 on ClinicalTrials.gov

What this trial studies

Women identified as poor ovarian responders are assigned to receive somatropin (4 IU daily for 1 month) plus folic acid, DHEA plus folic acid for 12 weeks, or control care before undergoing an ICSI cycle. The study compares number and size of ovarian follicles and ICSI outcomes between the three groups. Participants are followed one month before stimulation in the growth hormone arm, 12 weeks in the DHEA arm, and through the ICSI cycle. Eligibility requires at least two poor-responder criteria (advanced maternal age or other risk factor, prior ≤3 oocytes, or low AFC/AMH) and excludes significant endocrine, pelvic, or severe male-factor causes of infertility.

Who should consider this trial

Good fit: Women with poor ovarian response—typically advanced maternal age or a history of ≤3 oocytes in prior cycles or low AFC/AMH—who do not have endocrine/metabolic disease, pelvic pathology, or severe male-factor infertility are ideal candidates.

Not a fit: Patients with active endocrine or metabolic disorders, uterine or tubal pathology (e.g., hydrosalpinx), severe male-factor infertility, or those with normal ovarian reserve are unlikely to benefit from these interventions.

Why it matters

Potential benefit: If successful, the interventions could increase follicle number and size and potentially improve egg yield and ICSI success for women with poor ovarian reserve.

How similar studies have performed: Previous small trials and meta-analyses have shown mixed results, with some suggesting modest benefit from GH or DHEA in poor responders but overall evidence remains inconsistent and not definitive.

Eligibility criteria

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

Where this trial is running

Banī Suwayf, Beni Suweif Governorate

• Beni-Suef University Hospital — Banī Suwayf, Beni Suweif Governorate, Egypt (RECRUITING)

Conditions: Infertility, Growth hormone, IVF patients, Ovarian reserve