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

Phase 4

Completed

• Conditions: Female Infertility
• Interventions: Drug: Growth Hormone

• Registration Number: NCT05281341
• Lead Sponsor: Alexandria University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-13
• Status Verified: 2021-12
• Primary Completion: 2021-12-10
• Study Completion: 2022-02-13
• Study First Submitted: 2022-03-07
• Study First Submitted QC: 2022-03-07
• Study First Posted: 2022-03-16
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

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

Exclusion Criteria

1. Body mass index (BMI) >30 kg/m2.
2. Follicle Stimulating Hormone (FSH) > 15 IU/L.
3. History of abnormal karyotype in one or both partners.
4. Endocrine, metabolic or autoimmune disorders, such as diabetes, thyroid disorder, and polycystic ovary syndrome (PCOS).
5. Women with a known medical disease (e.g. severe hypertension or hepatic disease).
6. Endometriosis.
7. Previous ovarian surgery.
8. Current or history of malignancies, chemotherapy or radiotherapy.
9. Severe male actor (total motile sperm count <1×106 or normal morphology <1%)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Poseidon Group 4A & 3A	Growth Hormone	80 eligible infertile women fulfilling the criteria of Poseidon Group 4 (35 years or more and AMH \<1.2ng/ml) will be randomized into Group 4A will receive controlled ovarian stimulation (COS) and growth hormone (GH) and Group 4B will receive COS only. Similarly, 80 eligible infertile women fulfilling the criteria of Poseidon Group 3 (less than 35 years and AMH \<1.2ng/ml) will be randomized into Group 3A will receive COS and GH and Group 3B will receive COS only.

Primary Outcome Measures

Name	Time	Method
Live birth rate	28 gestational weeks	calculated as the number of live births (defined as at least one live born after 28 weeks of gestation) divided by the total number of patients who performed pregnancy tests.

Secondary Outcome Measures

Name	Time	Method
Serum E2 level	2-3 weeks	Serum Estradiol level on day of human chorionic gonadotropin (hCG) in pg.
Endometrial thickness	2-3 weeks	Endometrial thickness on day of hCG in mm
Fertilization rate	1 day after oocyte retrieval	number of 2pn oocytes to the total number of injected oocytes
Number of day 3 embryos	3 days after oocyte retrieval	Total number of available embryos on day 3 after oocyte retrieval
Clinical pregnancy rate	2 weeks after positive pregnancy test	Calculated as the number of clinical pregnancies (defined as the presence of a gestational sac with positive heart beat detected by transvaginal ultrasound scan 2 weeks after positive pregnancy test) divided by the number of embryo transfer procedures
Implantation rate	2 weeks after positive pregnancy test	Calculated as the ratio of the number of gestational sacs detected by sonography to the total number of embryos transferred
Miscarriage rate	20 weeks	The number fetal losses per clinical pregnancies

Trial Locations

Locations (1)

faculty of medicine, Alexandria University; 🇪🇬 Alexandria, Egypt