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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05585177
• Other study ID #: SZ-2022-GH
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: October 30, 2025

Study information

• Verified date: October 2022
• Source: Nanjing University
• Contact: Qingqing Shi, PHD
• Phone: 025-83106666
• Email: qqshnju[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 34 Years

Eligibility

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;

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Growth hormone
3 months of growth hormone treatment (2 units daily)

Locations

Country	Name	City	State
China	Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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