Growth Hormone and Dehydroepiandrosterone Role in Vitro Fertilization

Phase 3RecruitingNCT07323329

Beni-Suef University165 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

165

Conditions

Infertility Infertility (IVF Patients)

Interventions

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 dayDRUG

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

control groupDIETARY_SUPPLEMENT

Patients will receive folic acid 400 mcg per day

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

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

Locations (1)

Beni-Suef University Hospital

Banī Suwayf, Beni Suweif Governorate, Egypt

RECRUITING

Outcomes

Primary Outcomes

The number of mature oocyte

Time frame: 12 weeks

Secondary Outcomes

pregnancy rate

Time frame: 12 weeks

Data from ClinicalTrials.gov

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