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

Primary Purpose

Infertility

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Growth hormone
Sponsored by
Nanjing University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

20 Years - 34 Years (Adult)FemaleDoes not accept healthy volunteers

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;

Sites / Locations

  • Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Growth hormone pretreatment+IVF/ICSI

IVF/ICSI

Arm Description

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

IVF/ICSI was performed

Outcomes

Primary Outcome Measures

Number of embryos
When at least one dominant follicle reached a diameter of 18 mm or higher, 0.2 mg triptorelin was combined with 10000IU human chorionic gonadotropin as the trigger, and ovarian puncture was performed 36 hours later for oocyte retrieval. The number of embryos formed after three days of combined sperm and egg culture in vitro was recorded.

Secondary Outcome Measures

The number of oocytes retrieved
When at least one dominant follicle reached a diameter of 18 mm or higher, 0.2 mg triptorelin was combined with 10000IU human chorionic gonadotropin as the trigger, and ovarian puncture was performed 36 hours later for oocyte retrieval. The number of oocytes retrieved was recorded.
Clinical pregnancy rate
Clinical pregnancy was defined as diagnosed by increasing serum concentration of beta-Human chorionic gonadotropin 14 days after embryo transfer, and the subsequent demonstration of an intrauterine gestational sac by ultrasonography on 30 days after embryo transfer

Full Information

First Posted
October 15, 2022
Last Updated
October 20, 2022
Sponsor
Nanjing University
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1. Study Identification

Unique Protocol Identification Number
NCT05585177
Brief Title
Growth Hormone to Improve the Clinical Outcome of Assisted Fertility in Young Patients With Decreased Ovarian Reserve
Official Title
A Randomized Controlled Trial of Growth Hormone to Improve the Clinical Outcome of Assisted Fertility in Young Patients With Decreased Ovarian Reserve
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
October 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Growth hormone pretreatment+IVF/ICSI
Arm Type
Experimental
Arm Description
After 3 months of Growth hormone treatment (2 units daily), IVF/ICSI was performed
Arm Title
IVF/ICSI
Arm Type
No Intervention
Arm Description
IVF/ICSI was performed
Intervention Type
Drug
Intervention Name(s)
Growth hormone
Other Intervention Name(s)
IVF/ICSI
Intervention Description
3 months of growth hormone treatment (2 units daily)
Primary Outcome Measure Information:
Title
Number of embryos
Description
When at least one dominant follicle reached a diameter of 18 mm or higher, 0.2 mg triptorelin was combined with 10000IU human chorionic gonadotropin as the trigger, and ovarian puncture was performed 36 hours later for oocyte retrieval. The number of embryos formed after three days of combined sperm and egg culture in vitro was recorded.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
The number of oocytes retrieved
Description
When at least one dominant follicle reached a diameter of 18 mm or higher, 0.2 mg triptorelin was combined with 10000IU human chorionic gonadotropin as the trigger, and ovarian puncture was performed 36 hours later for oocyte retrieval. The number of oocytes retrieved was recorded.
Time Frame
4 months
Title
Clinical pregnancy rate
Description
Clinical pregnancy was defined as diagnosed by increasing serum concentration of beta-Human chorionic gonadotropin 14 days after embryo transfer, and the subsequent demonstration of an intrauterine gestational sac by ultrasonography on 30 days after embryo transfer
Time Frame
5-8months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age < 35 years; AFC≤5 Follicle stimulating hormone > 10miu/ml; Anti-mullerian hormone < 1.1μg/L (2 out of 2-4 items can be met) Exclusion Criteria: 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; Patients with severe adenomyosis, endometriosis, intrauterine adhesions and other diseases that significantly affect embryo implantation; Diabetes mellitus, insulin resistance; chromosomal karyotype abnormality in either spouse; Any pregnancy or contraindications of assisted reproductive technology;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qingqing Shi, PHD
Phone
025-83106666
Email
qqshnju@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haixiang Sun, PHD
Organizational Affiliation
The affiliated Drum Towel Hospital of Nanjing University Medical School
Official's Role
Study Director
Facility Information:
Facility Name
Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haixiang Sun
Phone
025-83107188
Email
stevensunz@163.com

12. IPD Sharing Statement

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

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