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Effect of GH Supplementation on the Blastocyst Euploid Rate in AMA Patients--A Retrospective Cohort Study

Sponsor
ShangHai Ji Ai Genetics & IVF Institute (Other)
Overall Status
Completed
CT.gov ID
NCT05574894
Collaborator
(none)
692
Enrollment
1
Location
2
Arms
20.9
Actual Duration (Months)
33.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This retrospective cohort study aims to investigate the effects of recombinant human growth hormone (rh-GH) on the euploid status of preimplantation blastocysts in AMA patients.

Infertile patients aged 38-46 years old were recruited for study if they fulfill the inclusion criteria and do not have the exclusion criteria.

Treatment group: Women received growth hormone (GH) supplement during antagonist protocol for ovarian stimulation.

Control group: Women received antagonist protocol for ovarian stimulation. The primary outcome is the euploidy rate of blastocysts per stimulation cycle and per testing cycle.

Condition or Disease Intervention/Treatment Phase
  • Drug: Growth hormone
  • Drug: GnRH antagonist
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
692 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effect of GH Supplementation on the Blastocyst Euploid Rate in AMA Patients--A Retrospective Cohort Study
Actual Study Start Date :
Jan 1, 2021
Actual Primary Completion Date :
Jun 30, 2022
Actual Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: GH group

Growth Hormone supplement, GnRH antagonist protocol for ovarian stimulation

Drug: Growth hormone
Growth hormone is supplemented during the ovarian stimulation till the day of trigger

Drug: GnRH antagonist
GnRH antagonist protocol for ovarian stimulation
Active Comparator: Control group

No Growth Hormone supplement, GnRH antagonist protocol for ovarian stimulation

Drug: GnRH antagonist
GnRH antagonist protocol for ovarian stimulation

Outcome Measures

Primary Outcome Measures

  1. euploidy rate per cycle [1 month after oocyte retrieval]

    euploidy rate of blastocysts, calculated per stimulation cycle and per testing cycle

Secondary Outcome Measures

  1. ongoing pregnancy rate [12 weeks' gestation]

    ongoing pregnancy is defined as a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer. Ongoing pregnancy rate=number of ongoing pregnancies/number of embryos transferred.

Eligibility Criteria

Criteria

Ages Eligible for Study:
38 Years to 46 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Age 38-46; BMI 18.5-24.0kg/m2; intended to undergo PGT-A; GnRH Antagonist protocol for ovarian stimulation; normal semen analysis for the male partner
Exclusion Criteria:

  • Endometriosis grade 3 or higher, untreat hydrosalpinx;

  • Women with a uterine cavity abnormality, such as a uterine congenital malformation (uterus uni-cornate, bicornate, or duplex);

  • Untreated uterine septum, adenomyosis, submucous myoma, or endo-metrial polyp(s)

  • Women who are indicated and planned to undergo PGT-SR (Preimplantation genetic testing for structural rearrangement) or PGT-M (Preimplantation genetic testing for monogenic disorder), for example, parental abnormal karyo-type or diagnosed with monogenic disease;

  • Women who received other supplement drugs during ovarian stimulation

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shanghai JIAI Genetics and IVF Institute Shanghai Shanghai China 200011

Sponsors and Collaborators

  • ShangHai Ji Ai Genetics & IVF Institute

Investigators

  • Study Director: Xiaoxi Sun, PhD, Shanghai JIAI Genetics and IVF Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ShangHai Ji Ai Genetics & IVF Institute
ClinicalTrials.gov Identifier:
NCT05574894
Other Study ID Numbers:
  • JIAI E2022-022
First Posted:
Oct 12, 2022
Last Update Posted:
Oct 12, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hormones

Study Results

No Results Posted as of Oct 12, 2022