Trial record 8 of 364 for:    PCOS

The Influence of Polycystic Ovairan Syndrome on Embryonic Developmental Timing (PCOS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Helene Nørrelund, University of Aarhus
ClinicalTrials.gov Identifier:
NCT01953146
First received: September 23, 2013
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

Polycystic ovary syndrome is one of the most common causes of female infertility. The cause of infertility in PCOS is unknown. Factors other than anovulation, including inherited or induced changes in the embryo quality have been suggested. Time-lapse analysis of embryo development is a sensitive method of detecting reduced embryo viability. Yet, there are no data regarding the embryo development in PCOS assessed by time-lapse analysis.


Condition
Polycystic Ovarian Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Timing of Development in Embryos Derived From Women With Polycystic Ovairan Syndrome and Controls

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Embryonic developmental timing assessed by Time-lapse analysis [ Time Frame: From fertilization until transfer at day 6 ] [ Designated as safety issue: No ]
    Embryos were cultured in a time-lapse incubator until arrest or removal at day 6. The time-point of an event was annotated and analyzed for the embryos in focus (in order of appearance).The influence of PCOS on embryo developmental timing was tested in regression models for patient-clustered data


Enrollment: 240
Study Start Date: September 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
PCOS criteria
nfertile patients undergoing assisted reproduction were consecutively recruited at the Fertility Clinic, Arhus University Hospital from February 2011 to May 2013. Women aged < 38 years without endometriosis where more than > 8 oocytes were retrieved were eligible. Patients were categorized in PCOS and non-PCOS according to the Rotterdam criteria for PCOS, defined by the presence of anovulation and polycystic ovaries.

Detailed Description:

Method A consecutive cohort of 249 infertile women attending In vitro fertilization (IVF) or Intra-cytoplasmic sperm injection (ICSI) treatment at the Fertility Clinic, Arhus University Hospital was requited from February 2011 to May 2013. 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 (Kirkegaard et al. 2013). Women aged < 38 years without endometriosis and with more than > 8 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. The Central Denmark Region Committees on Biomedical Research Ethics and the Danish Data Protection Agency approved the study.

Ovarian stimulation:

Patients were treated with individual doses of gonadotropin, based on serum AMH and/or antral follicle count. Patients were stimulated by either a GnRH agonist- or antagonist protocol using rec-FSH or HMG for stimulation according to clinical guidelines. A dose of 10,000 IU of hCG was administered when at least 3 follicles measured ≥ 17 mm, and UL 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 - 7th divisions, final divisions, compaction, morula, early and full expanded blastocyst, start of hatching and fully hatched 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 (Gardner et al. 2004) . 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, 313 embryos from 43 PCOS women, and 1080 embryos from 175 non-PCOS women were analyzed.

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

A consecutive cohort of 249 infertile women attending In vitro fertilization (IVF) or Intra-cytoplasmic sperm injection (ICSI) treatment at the Fertility Clinic, Arhus University Hospital from February 2011 to May 2013.

Criteria

Inclusion Criteria:

Women aged < 38 years without endometriosis and with more than > 8 oocytes retrieved were eligible. -

Exclusion Criteria:

  • All embryos with more or less than 2 pronuclei, and that did not undergo first cleavage were excluded
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01953146

Locations
Denmark
Fertility Clinic
Aarhus, N, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
Investigators
Study Director: Ulla B Knudsen, Professor Fertility Clinic Aarhus University
  More Information

No publications provided

Responsible Party: Helene Nørrelund, Consultant, University of Aarhus
ClinicalTrials.gov Identifier: NCT01953146     History of Changes
Other Study ID Numbers: PCOS_time-lapse
Study First Received: September 23, 2013
Last Updated: September 25, 2013
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
PCOS

Additional relevant MeSH terms:
Ovarian Diseases
Polycystic Ovary Syndrome
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Ovarian Cysts
Cysts
Neoplasms

ClinicalTrials.gov processed this record on April 15, 2014