Effect of Growth Hormone Injection on the IVF/ICSI Outcome of Patients With Poor Ovarian Reserve.

Not Applicable

• Conditions: Poor Ovarian Reserve
• Interventions: Drug: Polyethylene Glycol Recombinant Human Somatropin

• Registration Number: NCT04588844
• Lead Sponsor: Shandong University

Brief Summary

Declined fertility and ovarian reserve in older women are associated with lower density of Growth hormone (GH) receptors and dysregulation in GH secretion. GH can regulate the expression of growth hormone receptor and strengthen the function of mitochondria, which could improve the quality of the female oocyte. In this study, a prospective randomized control will be conducted to explore the effect of GH adjuvant therapy on clinical outcome of in vitro fertilization.

Detailed Description

Eligible subjects will be randomly assigned into either the study groups (receive somatropin co-treatment) or the control group (without sopmatropin treatment). Polyethylene glycol recombinant human somatropin will be injected weekly (3mg/per week) for approximately 6 weeks, i.e. from the beginning of preceding menstruation cycle until the day of ovum pickup. Both groups will receive a similar common protocol for ovarian stimulation. In vitro fertilization with or without intracytoplasmic sperm injection will be performed according to semen parameters. All embryos will undergo culture for blastocyst and the obtained blastocysts will be vitrified for deferred frozen embryo transfer. The Blastocyst formation rate will be the primary outcome measure.

Study Timeline

• Status Verified: 2020-10
• Study First Submitted: 2020-10-09
• Study First Submitted QC: 2020-10-09
• Last Update Submitted: 2020-10-09
• Study First Posted: 2020-10-19
• Last Update Posted: 2020-10-19
• Study Start: 2020-12-01
• Primary Completion: 2022-03-20
• Study Completion: 2023-03-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• 1)Married women between 35-40 years old; 2) serum AMH< 1.2ng/ml, and basal FSH<20IU/L during the screening period or within 6 months; 3) 18kg/m2≤BMI<30kg/m2; 4) Previous ART cycles <3.

Exclusion Criteria

• 1）Gynecological diseases that affect pregnancy outcomes, such as submucous uterine myoma, intramural uterine myoma≥4cm, Ovarian cyst≥4cm, endometriosis, Uterine malformation, Tuberculosis of reproductive system; 2) Spontaneous abortion≥3 times; 3) Chromosomal abnormalities (except polymorphism) in one or both spouses; 4) Patients with well-defined and uncontrolled endocrine, metabolic, and adrenal diseases, such as diabetes, thyroid disease, Cushing's syndrome; 5) Patients with malignant tumors; 6) Previous use of somatropin products.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Growth Hormone group	Polyethylene Glycol Recombinant Human Somatropin	Growth Hormone pretreatment for 6 weeks before ovarian stimulation

Primary Outcome Measures

Name	Time	Method
Live birth rate	One year
Blastocyst formation rate	One year	the number of blastocyst/ the total number of embryos underwent blastocyst culture ×100%

Secondary Outcome Measures

Name	Time	Method
Endometrial thickness on triggering day	One year
Number of high-score embryos	One year
Ongoing pregnancy rate	One year
total amount of Gn used	One year
clinical pregnancy rate	One year
Number of retrieved oocytes	One year
E2 levels on triggering day	One year
total days of Gn administration	One year