Cumulative Live Birth Rate With eSET After Preimplantation Genetic Screening Versus Conventional In-vitro Fertilization

Conditions

Infertility

Keywords

preimplantation genetic screening, single embryo transfer, frozen embryo transfer, cumulative live birth rate

Brief summary

The purpose of this randomized clinical trial is to compare the efficacy and safety with transfer of embryos selected by next generation sequencing (NGS) versus conventional morphological criteria. Subjects with 3 or more blastocysts on day 5 of embryo culture will be randomized to the PGS or IVF group. A Freeze-all strategy and a single frozen blastocyst transfer will be performed in both PGS and IVF groups. The primary outcome is the cumulative live birth after transfers of up to 3 single blastocycsts in both groups.

Detailed description

This is a multicenter, randomized clinical trial comparing the efficacy and safety with transfer of embryos selected by next generation sequence (NGS) and morphologic criteria versus by morphological criteria alone. Subjects who obtain 3 or more good-quality blastocysts will be randomized to PGS or IVF group. All embryos will be frozen and a single thawed blastocyst will be transferred in both PGS and IVF group. Subjects in the PGS group will have 3 blastocysts sequenced and euploid embryos will be subsequently transferred. Subjects in the IVF group will have blastocysts selected by morphology assessment. The cumulative live birth rate will be counted after transfers of all euploid embryo in the PGS group and 3 blastocysts in the IVF group within 1 year after randomization.

Guo L, Zhao B, Peng Z, Wei K, Chen ZJ, Yan J, Li Y, Xu X, Lu N, Su Y.

2025-12-16

10.1007/s10815-025-03773-2

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Oligoasthenospermia is correlated with increased preeclampsia incidence in subfertile couples undergoing in vitro fertilization and embryo transfer: a secondary analysis of a randomized clinical trial.

Guo L, Guo A, Lan X, Tian S, Sun F, Su Y, Chen ZJ, Cao Y, Li Y.

2024-08-15

10.1016/j.xfss.2024.08.003

Excessive Exogenous Gonadotropins and Genetic and Pregnancy Outcomes After Euploidy Embryo Transfer

Tianxiang Ni, Wei Zhou, Yingbo Liu, Weiran Cui, Liu Yang et al. (10 authors)

JAMA Network Open2024-04-022 citations

10.1001/jamanetworkopen.2024.4438

Comparative analysis of pregnancy outcomes in preimplantation genetic testing for aneuploidy and conventional in vitro fertilization and embryo transfer: a stratified examination on the basis of the quantity of oocytes and blastocysts from a multicenter randomized controlled trial.

Hu M, Liu M, Tian S, Guo L, Zang Z, Chen ZJ, Li Y.

2024-02-156 citations

10.1016/j.fertnstert.2024.02.023

Live Birth with or without Preimplantation Genetic Testing for Aneuploidy

Junhao Yan, Yingying Qin, Han Zhao, Yun Sun, Fei Gong et al. (33 authors)

New England Journal of Medicine2021-11-24289 citations

10.1056/nejmoa2103613

Interventions

PROCEDUREblastocyst morphologic score

Blastocysts will be scored by Gardner morphologic criteria.

PROCEDUREblastocyst biopsy and sequencing

Three blastocysts will be biopsied on trophectoderm, sequenced with next-generation sequencing (NGS). Euploidy will transferred one by one according to morphologic score.

PROCEDUREfreeze-all and single thawed blastocyst transfer

All blastocysts will be vitrified in fresh cycle. Single blastocyst will be thawed and transferred.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 37 Years

Healthy volunteers

No

Inclusion criteria

1. Women who are participating in their first cycle of IVF or ICSI 2. Women ages 20 to 37 years. 3. Women who obtain 3 or more good-quality blastocysts defined as morphological score of inner cell mass B or A, trophectoderm C or better, and grade 4 or better on day 5 of embryo culture will be randomized.

Exclusion criteria

1. 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); or with history of intrauterine adhesions. 2. Women with untreated hydrosalpinx; 3. Women who are indicated and planned to undergo PGD, for example, parental abnormal karyo-type or diagnosed with monogenic disease; 4. Women who use donated oocytes or sperm to achieve pregnancy; 5. Women with contraindication for assisted reproductive technology or for pregnancy, such as poorly controlled Type I or Type II diabetes; undiagnosed liver disease or dysfunction (based on se-rum liver enzyme testing); renal disease or abnormal serum renal function; significant anemia; history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; uncontrolled hyper-tension, known symptomatic heart disease; history of or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma; undiagnosed vaginal bleeding.

Design outcomes

Primary

Measure	Time frame	Description
Cumulative live birth rate	22 months	Live birth is defined as the delivery of any viable infant at 28 weeks or more of gestation after our interventions, and cumulative live birth rate is calculated by dividing the number of women achieving live birth after transfers of all study-specific embryos (up to 3 transfers of single blastocycst within 1 year after randomization), by the total number of women randomized to the specific group.

Secondary

Measure	Time frame	Description
Multiple pregnancy rate	22 months	Number of multiple pregnancies / number of clinical pregnancies over (up to) 3 transfers within 1 year.
Birth weight	22 months	Weight of newborns at delivery.
Cumulative incidence of maternal and neonatal complications during whole gestation and prenatal stage	22 months	Number of pregnancies with complications / number of pregnancies over (up to) 3 transfers within 1 year;number of live births with neonatal complications / number of live births over (up to)3 transfers within 1 year.
Number of embryo transfers to achieve live birth	22 months	Number of embryo transfers the patients have gone through to achieve live birth.
Rate of Good Birth Outcomes	22 months	Number of good birth outcomes / number of clinical pregnancies over (up to) 3 transfers within 1 year.Good Birth Outcome is defined as live birth of an infant born at ≥ 37 weeks, with a birth weight between 2500 and 4000g and without a major congenital anomaly.
Cumulative pregnancy rate	14 months	Number of women with clinical pregnancies over (up to) 3 transfers within 1 year / number of women randomized to the specific group. Clinical pregnancy will be diagnosed with detection of an intrauterine gestational sac.
Cumulative pregnancy loss rate	19 months	Number of pregnancy losses / number of clinical pregnancies over (up to) 3 transfers within 1 year.Pregnancy loss refers to a complete spontaneous abortion or a nonviable pregnancy before 28 weeks of gestation.
Duration of pregnancy	22 months	The time from the first day of last menstrual period to the day of delivery.

Other

Measure	Time frame	Description
Live birth rate after the first transfer	12 months	Number of women with live births after the first transfer / number of women randomized to the specific group.
Pregnancy loss rate after the first transfer	9 months	Number of pregnancy losses / number of clinical pregnancies after the first transfer .
Clinical pregnancy rate after the first transfer	4 months	Number of women with clinical pregnancies after the first transfer / number of women randomized to the specific group.

Countries

China

Contacts

Primary ContactZi-Jiang Chen, Professor

chenzijiang@vip.163.com+0086 531 85651190

Outcome results

None listed