Growth Hormone to Improve the Clinical Outcome of Assisted Fertility in Young Patients With Decreased Ovarian Reserve

Study Overview
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Brief Summary
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This study was a prospective randomized controlled trial. Patients aged <35 years with decreased clinical reserve function (AFC<5, Follicle stimulating hormone > 10miu/ml, Anti-mullerian hormone < 1.1μg/L) and receiving IVF/ICSI assisted ovulation induction in our hospital were included in this study. After randomization using Excel(Microsoft Corporation, Albuquerque, USA), these patients were divided into two groups. Group A was the experimental group, which was treated with growth hormone for 3 months (2 units per day) before IVF/ICSI. Group B was the control group, which was directly assisted by IVF/ICSI.

Official Title
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A Randomized Controlled Trial of Growth Hormone to Improve the Clinical Outcome of Assisted Fertility in Young Patients With Decreased Ovarian Reserve

Conditions
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Infertility

Intervention / Treatment
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* Drug: Growth hormone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age < 35 years; AFC≤5 Follicle stimulating hormone > 10miu/ml; Anti-mullerian hormone < 1.1μg/L (2 out of 2-4 items can be met) Exclusion Criteria: Severe male factors: spermatozoa collected by testicular sperm aspiration (TESA) or percutaneous epididymal sperm aspiration (PESA) was used for intracytoplasmic sperm injection (ICSI) cycle of single spermatozoa; Patients with severe adenomyosis, endometriosis, intrauterine adhesions and other diseases that significantly affect embryo implantation; Diabetes mellitus, insulin resistance; chromosomal karyotype abnormality in either spouse; Any pregnancy or contraindications of assisted reproductive technology;

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 34 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Growth hormone pretreatment+IVF/ICSI<br>After 3 months of Growth hormone treatment (2 units daily), IVF/ICSI was performed | Drug: Growth hormone<br>* 3 months of growth hormone treatment (2 units daily)<br>* Other names: IVF/ICSI;|
| No Intervention: IVF/ICSI<br>IVF/ICSI was performed | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of embryos | When at least one dominant follicle reached a diameter of 18 mm or higher, 0.2 mg triptorelin was combined with 10000IU human chorionic gonadotropin as the trigger, and ovarian puncture was performed 36 hours later for oocyte retrieval. The number of embryos formed after three days of combined sperm and egg culture in vitro was recorded. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of oocytes retrieved | When at least one dominant follicle reached a diameter of 18 mm or higher, 0.2 mg triptorelin was combined with 10000IU human chorionic gonadotropin as the trigger, and ovarian puncture was performed 36 hours later for oocyte retrieval. The number of oocytes retrieved was recorded. | 4 months | 
| Clinical pregnancy rate | Clinical pregnancy was defined as diagnosed by increasing serum concentration of beta-Human chorionic gonadotropin 14 days after embryo transfer, and the subsequent demonstration of an intrauterine gestational sac by ultrasonography on 30 days after embryo transfer | 5-8months |