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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Poor Ovarian Reserve
• Intervention / Treatment: Drug: Polyethylene Glycol Recombinant Human Somatropin

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daimin Wei; Phone Number: 0531-85652419; Email: sdweidaimin@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Growth Hormone group; Growth Hormone pretreatment for 6 weeks before ovarian stimulation	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.
NO_INTERVENTION: Control group; No pretreatment before ovarian stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Live birth rate		One year
Blastocyst formation rate	the number of blastocyst/ the total number of embryos underwent blastocyst culture ×100%	One year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shandong University
• Collaborators: The Second Hospital of Hebei Medical University; RenJi Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2020
• Primary Completion (ANTICIPATED): March 20, 2022
• Study Completion (ANTICIPATED): March 20, 2023

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (ACTUAL): October 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 9, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: PEG-rhGH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol and statistical analysis plan will be available online with publication. Data collected for the study, including specified data set and a data dictionary defining each field in the set, will be made available to others with publication.
• IPD Sharing Time Frame: After publication and for 1 year
• IPD Sharing Access Criteria: Investigators can request data sharing by contacting the email of the corresponding author. Our publication committee established for this trial will review and approve the request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No