Growth Hormone and Dehydroepiandrosterone Role in Vitro Fertilization

ConditionsInfertility Infertility (IVF Patients)

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexFemale

Age18-35

SponsorBeni-Suef University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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].

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

165 Participants

are divided into 3 treatment groups

Group A: Somatropin groupExperimental treatment 1 intervention

Group B: dehydroepiandrosteroneExperimental treatment 1 intervention

Group C: Standard careActive comparator 1 intervention

Trial outcomes

Primary outcomes

The number of mature oocyte

Time frame

12 weeks

Secondary outcomes

pregnancy rate

Time frame

12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beni-Suef University

Lead sponsor

Source ClinicalTrials.gov

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