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Effect of GH on the Blastocyst Euploid Rate in AMA Patients

ConditionsPreimplantation Genetic TestingGrowth HormoneAge, Parental
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age38+
SponsorShangHai Ji Ai Genetics & IVF Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥38; intended to undergo PGT-A

BMI in the normal range (18.50-24.0kg/m2)

Normal semen analysis for the male partner

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Treatment groupExperimental treatment 2 interventions
Group B: Control groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

euploidy rate

euploidy rate of blastocysts

Time frame
1 month after oocyte retrieval

Secondary outcomes

1

live birth rate

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

Time frame
1 year after embryo transfer
2

cumulative live birth rate

cumulative live birth within 6 months of randomization

Time frame
1 year after embryo transfer
3

ongoing pregnancy

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

Time frame
12 weeks' gestation
4

clinical pregnancy rate

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

Time frame
6 weeks after embryo transfer

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ShangHai Ji Ai Genetics & IVF Institute

Lead sponsor

Source ClinicalTrials.gov
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