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PCOSNCT05438355

The Effect of Polycystic Ovary Syndrome on the Embryo Morphokinetics ( PCOS )

An observational study of PCOS, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 37 years, women only
Conditions the study is for
PCOS
How many people
153 participants
Where
1 siteChina
Study dates
1 Mar 2021to 30 Dec 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 37 years
  • Women only
  • No healthy volunteers
  • Adult

Study population: Infertility patients udergoing IVF/ICSI cycles at Shanghai JiAi G-IVF institute from March 2021 to December 2021.

Who may be able to join

  • Women aged < 38 years without endometriosis and with more than 6 oocytes retrieved were eligible.

Who cannot join

  • All embryos with more or less than 2 pronuclei, and that did not undergo first cleavage were excluded

Trial locations and contacts

1 site in 1 country.

China1 site
  • Ji Ai Genetics and IVF center

    Shanghai, Shanghai Municipality, 200021

Other trials in China

About this study

Official title: The Effect of Polycystic Ovary Syndrome on the Morphokinetics or Abnormalities on Early Embryonic Development: a Time Lapse Study

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.

Read the detailed description

Method:

A consecutive cohort of 153 infertile women attending In vitro fertilization (IVF) or Intra-cytoplasmic sperm injection (ICSI) treatment at Shanghai Ji Ai G-IVF institute was requited from March 2021 to December 2021. During the period, couples undergoing IVF/ICSI treatment were offered blastocyst culture to day 6 and time-lapse imaging (TLI) as part of a study evaluating parameters for embryo selection. Women aged < 38 years without endometriosis and with more than 6 oocytes retrieved were eligible. Patients were categorized in two groups. Women with regular menstrual cycles and no clinical signs of PCOS (non-PCOS) and women fulfilling the Rotterdam diagnostic criteria for PCOS detected by the presence of anovulation and polycystic ovaries (PCO), which was diagnosed by luteal-phase progesterone testing and trans-vaginal ultrasound, respectively. Biochemical parameters of androgen excess were included in the diagnosis when available, whereas subjective symptoms of androgen excess (acne, hirsutism, alopecia) were not included. Ethical approval Written informed consent was obtained from all patients before inclusion. Shanghai Ji Ai ethical Committees approved the study.

Ovarian stimulation:

Patients were treated with individual doses of gonadotropin, based on serum anti-mullerian hormone (AMH) and/or antral follicle count. Patients were stimulated by gonadotropin-releasing hormone (GnRH) antagonist protocol using rec-follicle stimulating hormone (FSH) or human menopausal gonadotropin (HMG) for stimulation according to clinical guidelines. A dose of 10,000 IU of human chorionic gonadotropin (hCG) was administered when at least 3 follicles measured ≥ 17 mm, and ultrasound guided oocyte retrieval was conducted 36 h later. Oocyte retrieval and ICSI/IVF Ovarian stimulation and oocyte retrieval were performed according to standard procedures. After fertilization, ICSI embryos were immediately placed in the time-lapse incubator (EmbryoScope™). IVF embryos were cultured for approximately 18 h in a conventional incubator. Before IVF embryos were transferred to the EmbryoScope, adhering cumulus cells were removed to ensure optimal image acquisition. In the EmbryoScope, all embryos were cultured until arrest or removal at day 6.

Embryo assessment:

All embryos with 2 pronuclei completing the first cleavage were annotated manually. The following parameters were annotated with time points: appearance and disappearance of 1st nucleus and 2nd nucleus after 1st division, 1st - third divisions and blastocyst. All time-points were normalized to first cleavage and treated as durations for further analysis in order to overcome the limitation of inexact starting points, and facilitate comparison between IVF and ICSI populations. For the same reason, no parameters before first cleavage were investigated. Durations of cell cycles and cell stages were subsequently calculated as the interval between two time-points. Two parameters (multi-nucleation and direct cleavage to 3-cell stage) were assessed by binary values yes and no. Embryos were selected for transfer according to conventional measures of morphological quality on day 6 according to the Gardner criteria. No time-lapse parameters were used in the selection process. The observer was blinded to the patient's treatment data and medical history.

Statistics:

The influence of PCOS on embryo development was tested in regression models for clustered data. A covariance regression model was used to account for potential confounding variables: female age, BMI and fertility treatment. In total, 768 embryos from 80 PCOS women, and 676 embryos from 73 non-PCOS women were analyzed.

Conditions
PCOS
Keywords
PCOS, Time-lapse, Infertility, Morphokinetics
Medical subject headings
Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05438355
Study groupRoleWhat they receive
The infertility women with PCOSInfertile 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 PCOSInfertility 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Embryonic developmental timing

    Embryonic developmental timing assessed by Time-lapse analysis

    Measured: From fertilization until transfer at day 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2022
  2. Study start1 Mar 2021
  3. Primary completion1 Dec 2021
  4. Study completion30 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
153 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05438355
Sponsor's protocol ID
2022JIAI-06
Status last verified
Jul 2022
First submitted
21 Jun 2022
Last updated
6 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 14711538
  • Kirkegaard 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.

    PubMed 23900207
  • Gardner 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.

    PubMed 15037401

Questions about this trial

What is this clinical trial studying?

An observational study of PCOS, run by ShangHai Ji Ai Genetics & IVF Institute at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Embryonic developmental timing (time frame: From fertilization until transfer at day 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05438355, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2022.

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