Comparison of Clinical Outcomes in Fresh Cycle With Single Blastocyst Stage and Double Cleavage-stage Embryos: a Single-center, Non-blind, Randomized Controlled Study
1 other identifier
interventional
1,236
0 countries
N/A
Brief Summary
In traditional assisted reproductive technology (ART), choosing multiple embryo transfer to get a high clinical pregnancy rate while increasing the risk of multiple pregnancies. Research showed that the single-cleavage embryo transfer could not simultaneously meet the dual requirements of maintaining pregnancy rate and reducing the multiple pregnancy rate.The purpose of this study was to observe the clinical outcome between double cleavage embryo transfers and single blastocyst transfers in fresh cycle through RCT study with GnRH antagonist protocol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2022
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2022
CompletedFirst Posted
Study publicly available on registry
December 1, 2022
CompletedStudy Start
First participant enrolled
December 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedDecember 1, 2022
November 1, 2022
1.7 years
November 20, 2022
November 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
live birth rate per fresh transfer
live birth, which was defined as the presence of a live fetus (or feti) after the 24th week of gestational age
2 year
Study Arms (2)
Double Cleavage-stage Embryos transfer
OTHERIn group A, two embryos at cleavage stage were transplanted on the third day after oocyte retrieval.
Single Blastocyst Stage Embryos transfer
OTHERGroup B was graded by Gardner blastocyst grading method, and one blastocyst was transplanted on the 5th or 6th day after oocyte retrieval.
Interventions
Infertile women requesting in vitro fertilization treatment were randomly assigned to undergo transfer of either two cleavage-stage embryos or a single blastocyst-stage embryo.
Eligibility Criteria
You may qualify if:
- patients with a diagnosis of primary or secondary infertility with a clinical indication for IVF/intracytoplasmic sperm injection (ICSI)
- under 38 years of age
- number of AFC≥6, AMH\>1.1ng/ml
- no adverse factors of fresh embryo transplantation (evaluation by an experienced reproductive physician)
- number of available embryos(day 3)≥4
- informed consent
You may not qualify if:
- PGT
- with adenomyosis, endometrial compression by uterine fibroids, intrauterine adhesion, endometrial polyps and other factors unsuitable for fresh cycle transplantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 20, 2022
First Posted
December 1, 2022
Study Start
December 1, 2022
Primary Completion
August 1, 2024
Study Completion
December 1, 2024
Last Updated
December 1, 2022
Record last verified: 2022-11