The Effect of Polycystic Ovary Syndrome on the Embryo Morphokinetics ( PCOS )
1 other identifier
observational
153
1 country
1
Brief Summary
Polycystic ovarian syndrome (PCOS) is a complex endocrine and metabolic syndrome which accounts for 75% of women with anovulatory infertility. The cause of infertility in PCOS is already unknown. Although efforts have been made, many PCOS patients turned out to have worse oocyte maturity and IVF outcomes. Time-lapse analysis of embryo development can detect the abnormal timeline and cleavage mode which may affect the embryo viability of PCOS. However, there are still some debates on the effect of PCOS on the early embryo development by time-lapse analysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2021
Shorter than P25 for all trials
1 active site
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
Study Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedFirst Submitted
Initial submission to the registry
June 21, 2022
CompletedFirst Posted
Study publicly available on registry
June 29, 2022
CompletedJuly 6, 2022
July 1, 2022
9 months
June 21, 2022
July 1, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Embryonic developmental timing
Embryonic developmental timing assessed by Time-lapse analysis
From fertilization until transfer at day 6
Study Arms (2)
The infertility women with PCOS
Infertile women undergoing assisted reproduction were consecutively recruited at Ji Ai G-IVF institute from March 2021 to December 2021. Women aged \< 38 years without endometriosis and more than 6 oocytes were retrieved . Patients were divided in PCOS according to the Rotterdam criteria for PCOS, defined by the presence of anovulation and polycystic ovaries.
The infertility women without PCOS
Infertility women with fallopian tubal factor infertility and with normal menstrual cycles were undergoing IVF/ICSI cycles at Shanghai Ji Ai G-IVF institute from March 2021 to December 2021.Women aged \< 38 years without endometriosis and more than 6 oocytes were retrieved.
Eligibility Criteria
Infertility patients udergoing IVF/ICSI cycles at Shanghai JiAi G-IVF institute from March 2021 to December 2021.
You may qualify if:
- Women aged \< 38 years without endometriosis and with more than 6 oocytes retrieved were eligible.
You may not qualify if:
- All embryos with more or less than 2 pronuclei, and that did not undergo first cleavage were excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ji Ai Genetics and IVF center
Shanghai, Shanghai Municipality, 200021, China
Related Publications (3)
Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004 Jan;81(1):19-25. doi: 10.1016/j.fertnstert.2003.10.004.
PMID: 14711538RESULTKirkegaard K, Kesmodel US, Hindkjaer JJ, Ingerslev HJ. Time-lapse parameters as predictors of blastocyst development and pregnancy outcome in embryos from good prognosis patients: a prospective cohort study. Hum Reprod. 2013 Oct;28(10):2643-51. doi: 10.1093/humrep/det300. Epub 2013 Jul 30.
PMID: 23900207RESULTGardner DK, Surrey E, Minjarez D, Leitz A, Stevens J, Schoolcraft WB. Single blastocyst transfer: a prospective randomized trial. Fertil Steril. 2004 Mar;81(3):551-5. doi: 10.1016/j.fertnstert.2003.07.023.
PMID: 15037401RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xiaoxi Sun, PHD
Shanghai G-IVF institute
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2022
First Posted
June 29, 2022
Study Start
March 1, 2021
Primary Completion
December 1, 2021
Study Completion
December 30, 2021
Last Updated
July 6, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share