CompletedPhase 4

Effect of GH Administration in Poor Responders Undergoing Intracytoplasmic Sperm Injection (ICSI)

Egypt160 participantsStarted 2020-01-13

Plain-language summary

Despite the use of various treatment strategies, poor response to ovarian stimulation remains a major clinical challenge with lower chance to obtain sufficient number of oocytes and thus less likely to conceive with high risk of cycle cancellation. The aim of this study is to evaluate the effect of recombinant human GH administration to gonadotropins on clinical and laboratory ICSI outcomes in expected poor responders more and less than 35 years (Poseidon group 4 and 3 respectively).

Who can participate

Age range20 Years

SexFEMALE

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Inclusion criteria

✓. Infertile women aged 20-45 years.
✓. AFC \<5.
✓. AMH level \<1.2 ng/ml.
✓. Have two normal ovaries and normal uterine cavity.

Exclusion criteria

✕. Body mass index (BMI) \>30 kg/m2.
✕. Follicle Stimulating Hormone (FSH) \> 15 IU/L.
✕. History of abnormal karyotype in one or both partners.
✕. Endocrine, metabolic or autoimmune disorders, such as diabetes, thyroid disorder, and polycystic ovary syndrome (PCOS).
✕. Women with a known medical disease (e.g. severe hypertension or hepatic disease).
✕. Endometriosis.
✕. Previous ovarian surgery.
✕. Current or history of malignancies, chemotherapy or radiotherapy.

What they're measuring

Live birth rate

Timeframe: 28 gestational weeks

Trial details

NCT IDNCT05281341

SponsorAlexandria University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-12-10

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