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

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2025-10-30

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.

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Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Growth hormone pretreatment+IVF/ICSI

After 3 months of Growth hormone treatment (2 units daily), IVF/ICSI was performed

Group Type EXPERIMENTAL

Growth hormone

Intervention Type DRUG

3 months of growth hormone treatment (2 units daily)

IVF/ICSI

IVF/ICSI was performed

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Growth hormone

3 months of growth hormone treatment (2 units daily)

Intervention Type DRUG

Other Intervention Names

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IVF/ICSI

Eligibility Criteria

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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;

Minimum Eligible Age

20 Years

Maximum Eligible Age

34 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No