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

Alexandria University

Status and phase: Completed; Phase 4

Conditions: Female Infertility

Treatments: Drug: Growth Hormone

Study type: Interventional

Funder types: Other

Identifiers

NCT05281341

0305406

Details and patient eligibility

About

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).

Enrollment: 160 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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%)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Poseidon Group 4A & 3A

Experimental group

Description:

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.

Treatment:

Drug: Growth Hormone

poseidon Group 4B & 3B

No Intervention group

Description:

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.