Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05447208

Effect of GH on the Blastocyst Euploid Rate in AMA Patients

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Preimplantation Genetic Testing Age, Parental Growth Hormone

Age range

38 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Shanghai JIAI Genetics and IVF Institute

Shanghai, Shanghai Municipality, 200011, China

Location status: Recruiting

Location contact

Xiaoxi Sun, PhD

CONTACT

[email protected]

63459977

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥38; intended to undergo PGT-A
  • BMI in the normal range (18.50-24.0kg/m2)
  • 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
  • History of endocrine disorder, autoimmune diseases or diagnosed thrombophilia
  • History of GH supplementation in the previous IVF treatment or taking other supplementary drugs used during stimulation; patients with absolute or relative contraindications to GH treatment, including active malignancy or history of cancer, diabetic retinopathy, diabetes mellitus, and chronic kidney disease.

Treatment and study plan

growth hormone

Drug

Growth hormone is supplemented before and during the ovarian stimulation till the day of oocyte retrieval

GnRh antagonist

Drug

GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger

Primary outcomes

  1. euploidy rate

    Time frame: 1 month after oocyte retrieval

    euploidy rate of blastocysts

Secondary outcomes

  1. live birth rate

    Time frame: 1 year after embryo transfer

    deliveries ≥22 weeks gestation with heartbeat and breath of the first frozen embryo transfer

  2. cumulative live birth rate

    Time frame: 1 year after embryo transfer

    cumulative live birth within 6 months of randomization

  3. ongoing pregnancy

    Time frame: 12 weeks' gestation

    a viable pregnancy beyond 12 weeks' gestation of the first frozen embryo transfer

  4. clinical pregnancy rate

    Time frame: 6 weeks after embryo transfer

    the presence of intrauterine gestational sac by transvaginal ultrasound at 6 gestational weeks of the first frozen embryo transfer

  5. number of euploid blastocysts in an OS cycle

    Time frame: 1 month after oocyte retrieval

    the number of blastocysts acquired in an ovarian stimulation cycle that are identified as euploid by PGT-A

  6. the probability of obtaining euploid blastocysts in an OS cycle

    Time frame: 1 month after oocyte retrieval

    If the ovarian stimulation cycle produces euploid blastocysts, the result is 1; if not, it's 0. Mean values will be calculated for the two groups.

  7. KIDScore of euploid embryos

    Time frame: 6 days after oocyte retrieval

    an AI-driven embryo score generated through the EmbryoViewer software relying on kinetic parameters and associated with embryo implantation potential

Study contacts

Contact information is provided by the study sponsor or research team.

XIAOXI SUN, PhD

CONTACT

YILUN SUI, MD

CONTACT

[email protected]

86-13661553127

Sponsors and collaborators

Lead sponsor

ShangHai Ji Ai Genetics & IVF Institute

Other

Registry information

Official study title

A Randomized Control Trial to Investigate the Effect of Growth Hormone on the Euploid Rate of Blastocyst in Patients With Advanced Maternal Age

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jul 7, 2022
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.