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

Nanjing University120 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Infertility

Interventions

Growth hormone

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 34 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age \< 35 years; 2. AFC≤5 3. Follicle stimulating hormone \> 10miu/ml; 4. Anti-mullerian hormone \< 1.1μg/L (2 out of 2-4 items can be met) Exclusion Criteria: 1. 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; 2. Patients with severe adenomyosis, endometriosis, intrauterine adhesions and other diseases that significantly affect embryo implantation; 3. Diabetes mellitus, insulin resistance; 4. chromosomal karyotype abnormality in either spouse; 5. Any pregnancy or contraindications of assisted reproductive technology;

Outcomes

Primary Outcomes

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.

Time frame: 4 months

Secondary Outcomes

The number of oocytes retrieved

Time frame: 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

Time frame: 5-8months