Growth Hormone and Dehydroepiandrosterone Role in Vitro Fertilization

Beni-Suef University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Infertility; Infertility (IVF Patients)

Treatments: Dietary Supplement: control group; Drug: Somatropin (4IU for 1 month) plus, folic acid 400 mcg per day.; Drug: DHEA plus folic acid 400mcg per day

Study type: Interventional

Funder types: Other

Identifiers

NCT07323329

FMBSUREC/01092024/Ragab

Details and patient eligibility

About

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.

Enrollment: 165 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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165 participants in 3 patient groups

Somatropin group

Experimental group

Description:

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

Treatment:

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

dehydroepiandrosterone

Experimental group

Description:

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

Treatment:

Drug: DHEA plus folic acid 400mcg per day

Standard care

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: control group