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

NCT04588844 | Unknown

• 1 other identifier: PEG-rhGH
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Poor Ovarian Reserve

Outcome Measures

Primary Outcomes (2)

• Blastocyst formation rate

  the number of blastocyst/ the total number of embryos underwent blastocyst culture ×100%

  One year

• Live birth rate

  One year

Secondary Outcomes (8)

• 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

Study Arms (2)

Growth Hormone group

EXPERIMENTAL

Growth Hormone pretreatment for 6 weeks before ovarian stimulation

Drug: Polyethylene Glycol Recombinant Human Somatropin

Control group

NO INTERVENTION

No pretreatment before ovarian stimulation

Interventions

Polyethylene Glycol Recombinant Human Somatropin DRUG

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.

Growth Hormone group

Eligibility Criteria

• Age: 35 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• )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.

You may not qualify if:

• ）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.

Sponsors & Collaborators

• Shandong University: lead
• RenJi Hospital: collaborator
• The Second Hospital of Hebei Medical University: collaborator

Central Study Contacts

Daimin Wei

CONTACT

0531-85652419; sdweidaimin@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 19, 2020
• Study Start: December 1, 2020
• Primary Completion: March 20, 2022
• Study Completion: March 20, 2023
• Last Updated: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After publication and for 1 year
• 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.