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Comparison of Clinical Outcomes in Fresh Cycle With Single Blastocyst Stage and Double Cleavage-stage Embryos: a Single-center, Non-blind, Randomized Controlled Study

Comparison of Clinical Outcomes in Fresh Cycle With Single Blastocyst Stage and Double Cleavage-stage Embryos: a Single-center, Non-blind, Randomized Controlled Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05632731
Enrollment
1236
Registered
2022-12-01
Start date
2022-12-31
Completion date
2024-12-31
Last updated
2022-12-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Female

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.

Detailed description

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 in the fresh cleavage embryo transfer cycle, the clinical pregnancy rate increased with the increase of the number of high-quality embryos transferred, and so did the multiple pregnancy rate, suggesting that the single-cleavage embryo transfer could not simultaneously meet the dual requirements of maintaining pregnancy rate and reducing the multiple pregnancy rate. Compared with the embryo at cleavage stage, blastocyst culture is a process of survival of the fittest, which is physiologically more synchronized with endometrial development and can improve embryo implantation rate. The existing clinical research analysis is mostly limited to the down-regulating regimen, while the RCT study of high-quality with GnRH antagonist protocol is few. Therefore, 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.

Interventions

PROCEDUREdouble cleavage-stage or single blastocyst stage embryos transfer

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.

Sponsors

ORGANON (SHANGHAI) PHARMACEUTICAL TECHNOLOGY CO., LTD.
CollaboratorUNKNOWN
Women's Hospital School Of Medicine Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
No

Inclusion criteria

1. patients with a diagnosis of primary or secondary infertility with a clinical indication for IVF/intracytoplasmic sperm injection (ICSI) 2. under 38 years of age 3. number of AFC≥6, AMH\>1.1ng/ml 4. no adverse factors of fresh embryo transplantation (evaluation by an experienced reproductive physician) 5. number of available embryos(day 3)≥4 6. informed consent

Exclusion criteria

1. PGT 2. with adenomyosis, endometrial compression by uterine fibroids, intrauterine adhesion, endometrial polyps and other factors unsuitable for fresh cycle transplantation

Design outcomes

Primary

MeasureTime frameDescription
live birth rate per fresh transfer2 yearlive birth, which was defined as the presence of a live fetus (or feti) after the 24th week of gestational age

Contacts

Primary ContactYimin Zhu, Dr
zhuyim@zju.edu.cn0571-89992071

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026