NCT02377219

Brief Summary

Our goal is to prospect the relationships between Bisphenol A (BPA) exposure (measured as its free and conjugated forms in blood and urine) and embryo implantation rate (measured as the ratio between the number of gestational sacs and the number of transferred embryos) after assisted reproductive technology. In order to reduce the confusion factors, the population study is limited to young women (aged 28 to 34), with regular menstrual cycles and without any medical event that could affect the implantation process

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2013

Completed
10 months until next milestone

Study Start

First participant enrolled

October 1, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

July 15, 2019

Status Verified

July 1, 2019

Enrollment Period

4.8 years

First QC Date

December 17, 2013

Last Update Submit

July 11, 2019

Conditions

Female Reproductive ProblemMale Reproductive Problems

Outcome Measures

Primary Outcomes (1)

  • embryo implantation rate

    an ultrasonography between the 5th and 7th week after embryo transfer

    6 weeks after implantation

Secondary Outcomes (1)

  • serum AMH

    4 days after inclusion

Study Arms (1)

couples

EXPERIMENTAL

couples attending an IVF or intra cytoplasmic sperm injection (ICSI) attempt have hormonal and blood analysis

Other: hormonal and blood analysis

Interventions

hormonal and blood analysisOTHER
couples

Eligibility Criteria

Age28 Years - 34 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Regular menstrual cycles (between 27 and 33 days)
  • st or 2nd IVF or ICSI attempt with an embryo transfer at D2 or D3

You may not qualify if:

  • couple already included in the study
  • ovarian surgery history
  • uterine (malformation, diethylstilbestrol (DES) syndrome, adenomyosis…) or systemic pathology that can affect implantation (thrombophilia, antiphospholipids syndrome…)
  • chemotherapy history for the woman
  • any endocrinopathy (except dysthyroid) in the woman
  • endometriosis
  • ICSI with testicular sperm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University Hospital

Bordeaux, 33076, France

Location

CHRU Brest Hôpital Morvan, Service de Médecine de la Reproduction

Brest, France

Location

University Hospital

Dijon, 21000, France

Location

University Hospital

Lille, 59037, France

Location

CHU Limoges, Centre d'AMP

Limoges, France

Location

University Hospital

Nantes, 44093, France

Location

HOSPITAL

Poissy, 78303, France

Location

University Hospital

Toulouse, 31052, France

Location

Related Publications (2)

  • Corbel T, Gayrard V, Viguie C, Puel S, Lacroix MZ, Toutain PL, Picard-Hagen N. Bisphenol A disposition in the sheep maternal-placental-fetal unit: mechanisms determining fetal internal exposure. Biol Reprod. 2013 Jul 18;89(1):11. doi: 10.1095/biolreprod.112.106369. Print 2013 Jul.

    PMID: 23699389BACKGROUND

  • Leandri RD, Gachet A, Pfeffer J, Celebi C, Rives N, Carre-Pigeon F, Kulski O, Mitchell V, Parinaud J. Is intracytoplasmic morphologically selected sperm injection (IMSI) beneficial in the first ART cycle? a multicentric randomized controlled trial. Andrology. 2013 Sep;1(5):692-7. doi: 10.1111/j.2047-2927.2013.00104.x. Epub 2013 Jun 21.

    PMID: 23788532BACKGROUND

MeSH Terms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Roger LEANDRI, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2013

First Posted

March 3, 2015

Study Start

October 1, 2014

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

July 15, 2019

Record last verified: 2019-07

Locations

FR(8)