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

Poor Ovarian Reserve Clinical Trial

Official title:

Effect of Polyethylene Glycol Recombinant Human Growth Hormone Injection on the IVF/ICSI Outcome of Patients With Poor Ovarian Reserve

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04588844
• Other study ID #: PEG-rhGH
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: March 20, 2023

Study information

• Verified date: October 2020
• Source: Shandong University
• Contact: Daimin Wei
• Phone: 0531-85652419
• Email: sdweidaimin[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: March 20, 2023
• Est. primary completion date: March 20, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Poor Ovarian Reserve

Intervention

Drug:
• Polyethylene Glycol Recombinant Human Somatropin
Polyethylene glycol recombinant human somatropin will be injected weekly (3mg/per week) from the beginning of preceding menstruation cycle until the day of ovum pickup.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Shandong University	RenJi Hospital, The Second Hospital of Hebei Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blastocyst formation rate	the number of blastocyst/ the total number of embryos underwent blastocyst culture ×100%	One year
Primary	Live birth rate		One year
Secondary	Number of retrieved oocytes		One year
Secondary	Number of high-score embryos		One year
Secondary	total amount of Gn used		One year
Secondary	total days of Gn administration		One year
Secondary	clinical pregnancy rate		One year
Secondary	Ongoing pregnancy rate		One year
Secondary	E2 levels on triggering day		One year
Secondary	Endometrial thickness on triggering day		One year