Growth Hormone and Dehydroepiandrosterone Role in Vitro Fertilization
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Somatropin (4IU for 1 month) plus, folic acid 400 mcg per day., DHEA plus folic acid 400mcg per day, control group.
- Who it may be relevant to
- Registry conditions: Infertility, Infertility (IVF Patients). Basic parameters: 18 years — 35 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Growth Hormone and Dehydroepiandrosterone Effect on Poor Ovarian Reserve Patients During in Vitro Fertilization
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.
Interventions
- Drug Somatropin (4IU for 1 month) plus, folic acid 400 mcg per day.
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. - Drug DHEA plus folic acid 400mcg per day
Patients will receive DHEA 50 mg twice per day for 12 weeks plus folic acid 400mcg per day - Dietary supplement control group
Patients will receive folic acid 400 mcg per day
Primary outcome measures
- The number of mature oocyte [Time frame: 12 weeks]
Secondary outcome measures (1)
- pregnancy rate [Time frame: 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Beni-Suef University Hospital — Banī Suwayf
Publications
- Casson PR, Lindsay MS, Pisarska MD, Carson SA, Buster JE. Dehydroepiandrosterone supplementation augments ovarian stimulation in poor responders: a case series. Hum Reprod. 2000 Oct;15(10):2129-32. doi: 10.1093/humrep/15.10.2129. PMID 11006185
Identifiers
NCT: NCT07323329 · FMBSUREC/01092024/Ragab