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

Alexandria University160 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Female Infertility

Interventions

Growth HormoneDRUG

In GH groups (Group 4A \& 3A), patients will receive additional treatment with GH (Somatropin, 4 IU/day, subcutaneous injection), daily beginning on the initial day of gonadotropin stimulation until triggering the oocyte maturation by hCG. Control groups (Group 4B \& 3B) will receive only standard COS without GH supplementation

Eligibility

Sex: FEMALEMin age: 20 Years

Medical Language ↔ Plain English

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%)

Locations (1)

faculty of medicine, Alexandria University

Alexandria, Egypt

Outcomes

Primary Outcomes

Live birth rate

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.

Time frame: 28 gestational weeks

Secondary Outcomes

Serum E2 level

Serum Estradiol level on day of human chorionic gonadotropin (hCG) in pg.

Time frame: 2-3 weeks

Endometrial thickness

Endometrial thickness on day of hCG in mm

Time frame: 2-3 weeks

Fertilization rate

number of 2pn oocytes to the total number of injected oocytes

Time frame: 1 day after oocyte retrieval

Number of day 3 embryos

Total number of available embryos on day 3 after oocyte retrieval

Time frame: 3 days after oocyte retrieval

Clinical pregnancy rate

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

Time frame: 2 weeks after positive pregnancy test

Implantation rate

Calculated as the ratio of the number of gestational sacs detected by sonography to the total number of embryos transferred

Time frame: 2 weeks after positive pregnancy test

Miscarriage rate

Data from ClinicalTrials.gov

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