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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-13

Study Completion Date

2022-02-13

Brief Summary

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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).

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Detailed Description

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Conditions

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Female Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Poseidon Group 4A & 3A

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.

Group Type EXPERIMENTAL

Growth Hormone

Intervention Type DRUG

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

poseidon Group 4B & 3B

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Growth Hormone

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

Intervention Type DRUG

Other Intervention Names

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somatropin 4 IU

Eligibility Criteria

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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%)

Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No