- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05447208
Effect of GH on the Blastocyst Euploid Rate in AMA Patients
A Randomized Control Trial to Investigate the Effect of Growth Hormone on the Euploid Rate of Blastocyst in Patients With Advanced Maternal Age
This randomized trial aims to compare the euploid rate of blastocysts in AMA patients undergoing PGT-A (preimplantation genetic testing for aneuploidy) with or without growth hormone supplement.
Infertile patients ≥38 years old will be recruited for study after informed consent if they fulfill the inclusion criteria and do not have the exclusion criteria. Eligible women will be randomised into one of the two groups:
Treatment group: Women will receive growth hormone (GH) supplement before and during antagonist protocol for ovarian stimulation.
Control group: Women will receive antagonist protocol for ovarian stimulation. The primary outcome is the euploidy rate of blastocysts.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: YILUN SUI, MD
- Phone Number: 86-13661553127
- Email: 08301010255@fudan.edu.cn
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200011
- Recruiting
- Shanghai JiAi Genetics and IVF Institute
-
Contact:
- Xiaoxi Sun, PhD
- Phone Number: 63459977
- Email: xiaoxi__sun@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥38; intended to undergo PGT-A
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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment group
GH is supplemented during ovarian stimulation
|
Growth hormone is supplemented before and during the ovarian stimulation till the day of oocyte retrieval
GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger
|
Active Comparator: Control group
GH is not supplemented during ovarian stimulation.
|
GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
euploidy rate
Time Frame: 1 month after oocyte retrieval
|
euploidy rate of blastocysts
|
1 month after oocyte retrieval
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
live birth rate
Time Frame: 1 year after embryo transfer
|
deliveries ≥22 weeks gestation with heartbeat and breath of the first frozen embryo transfer
|
1 year after embryo transfer
|
cumulative live birth rate
Time Frame: 1 year after embryo transfer
|
cumulative live birth within 6 months of randomization
|
1 year after embryo transfer
|
ongoing pregnancy
Time Frame: 12 weeks' gestation
|
a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer
|
12 weeks' gestation
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Demko ZP, Simon AL, McCoy RC, Petrov DA, Rabinowitz M. Effects of maternal age on euploidy rates in a large cohort of embryos analyzed with 24-chromosome single-nucleotide polymorphism-based preimplantation genetic screening. Fertil Steril. 2016 May;105(5):1307-1313. doi: 10.1016/j.fertnstert.2016.01.025. Epub 2016 Feb 8.
- Weall BM, Al-Samerria S, Conceicao J, Yovich JL, Almahbobi G. A direct action for GH in improvement of oocyte quality in poor-responder patients. Reproduction. 2015 Feb;149(2):147-54. doi: 10.1530/REP-14-0494. Epub 2014 Nov 5.
- Gong Y, Luo S, Fan P, Jin S, Zhu H, Deng T, Quan Y, Huang W. Growth hormone alleviates oxidative stress and improves oocyte quality in Chinese women with polycystic ovary syndrome: a randomized controlled trial. Sci Rep. 2020 Oct 30;10(1):18769. doi: 10.1038/s41598-020-75107-4.
- Liu C, Li S, Li Y, Tian J, Sun X, Song T, Yan G, Ding L, Sun H. Growth hormone ameliorates the age-associated depletion of ovarian reserve and decline of oocyte quality via inhibiting the activation of Fos and Jun signaling. Aging (Albany NY). 2021 Feb 17;13(5):6765-6781. doi: 10.18632/aging.202534. Epub 2021 Feb 17.
- Skillern A, Leonard W, Pike J, Mak W. Growth hormone supplementation during ovarian stimulation improves oocyte and embryo outcomes in IVF/PGT-A cycles of women who are not poor responders. J Assist Reprod Genet. 2021 May;38(5):1055-1060. doi: 10.1007/s10815-021-02088-2. Epub 2021 Feb 3.
- Regan SLP, Knight PG, Yovich JL, Arfuso F, Dharmarajan A. Growth hormone during in vitro fertilization in older women modulates the density of receptors in granulosa cells, with improved pregnancy outcomes. Fertil Steril. 2018 Dec;110(7):1298-1310. doi: 10.1016/j.fertnstert.2018.08.018.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022JIAI-10
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Preimplantation Genetic Testing
-
ShangHai Ji Ai Genetics & IVF InstituteRecruitingGnRH Antagonist | Preimplantation Genetic Testing | Progestin-primed Ovarian Stimulation | Euploid RateChina
-
Unità di Medicina della Riproduzione, ItalyCompletedIncrease the Number of Blastocyst to Biopsy for Preimplantation Genetic TestingItaly
-
University Hospital, GhentNot yet recruitingQuality of Life | Ovarian Stimulation | Preimplantation Genetic Testing | Fertility Preservation
-
Mỹ Đức HospitalMy Duc Phu Nhuan HospitalUnknownICSI | Preimplantation Genetic Testing (PGT)Vietnam
-
Gokalp OnerRecruitingPreimplantation Genetic ScreeningTurkey
-
National Taiwan University HospitalUnknownPreimplantation Genetic Diagnosis (PGD)Taiwan
-
Universitaire Ziekenhuizen KU LeuvenKU Leuven; Universitair Ziekenhuis Brussel; Vrije Universiteit BrusselUnknownPreimplantation Genetic DiagnosisBelgium
-
Maastricht University Medical CenterUnknown
-
Natera, Inc.Ferring PharmaceuticalsTerminatedIn Vitro Fertilization (IVF) | Preimplantation Genetic Diagnosis (PGD) | Preimplantation Gentic Screening (PGS)United States
-
Aalborg University HospitalAarhus University Hospital; Rigshospitalet, Denmark; Horsens Hospital; Kolding... and other collaboratorsCompletedPreimplantation Genetic Diagnosis | Prenatal DiagnosesDenmark
Clinical Trials on Growth Hormone
-
The University of Texas Medical Branch, GalvestonCompletedMild Cognitive ImpairmentUnited States
-
University of PennsylvaniaNational Institute on Aging (NIA)TerminatedAging | Hormone DeficiencyUnited States
-
Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
University of WashingtonNational Institute on Aging (NIA)CompletedAging | Mild Cognitive ImpairmentUnited States
-
Massachusetts General HospitalCompleted
-
Massachusetts General HospitalNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedHealthy VolunteersUnited States
-
University of PennsylvaniaCompletedCongestive Heart FailureUnited States
-
Versartis Inc.Completed
-
Rabin Medical CenterPfizerCompleted
-
Massachusetts General HospitalActive, not recruitingObesity | Fatty Liver | Liver Fat | Obesity, Abdominal | Non-Alcoholic Fatty Liver DiseaseUnited States