Clinical trial NCT03118141: Cumulative Live Birth Rate With eSET After Preimplantation Genetic Screening Versus Conventional In-vitro Fertilization
Official title: Cumulative Live Birth Rate With eSET After In-vitro Fertilization With Preim-plantation Genetic Screening by Next Generation Sequencing Versus Conventional In-vitro Fertilization: A Pragmatic Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Keywords: preimplantation genetic screening
single embryo transfer
frozen embryo transfer
cumulative live birth rate
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital with Nanjing Medical University
name: Peking University Third Hospital
name: ShangHai Ji Ai Genetics & IVF Institute
name: RenJi Hospital
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Suzhou Municipal Hospital
name: Renmin Hospital of Wuhan University
name: Yantai Yuhuangding Hospital
name: Tang-Du Hospital
name: Nanjing Maternity and Child Health Care Hospital
name: Guangxi Maternal and Child Health Hospital
name: Women's Hospital School Of Medicine Zhejiang University
name: Guangdong Women and Children Hospital
name: Tianjin Central Hospital of Gynecology Obstetrics
name: Shengjing Hospital
name: The First Affiliated Hospital of Anhui Medical University
First posted: 2017-04-18
Enrollment: 1215
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Cumulative live birth rate
timeFrame: 22 months
Secondary outcomes:
measure: Rate of Good Birth Outcomes
timeFrame: 22 months
measure: Cumulative pregnancy rate
timeFrame: 14 months
measure: Cumulative pregnancy loss rate
timeFrame: 19 months
measure: Multiple pregnancy rate
timeFrame: 22 months
measure: Duration of pregnancy
timeFrame: 22 months
measure: Birth weight
timeFrame: 22 months
measure: Cumulative incidence of maternal and neonatal complications during whole gestation and prenatal stage
timeFrame: 22 months
measure: Number of embryo transfers to achieve live birth
timeFrame: 22 months
Other outcomes:
measure: Clinical pregnancy rate after the first transfer
timeFrame: 4 months
measure: Pregnancy loss rate after the first transfer
timeFrame: 9 months
measure: Live birth rate after the first transfer
timeFrame: 12 months
Locations:
city: Jinan
country: China
facility: Shandong University
state: Shandong
Study officials:
References:
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