NCT01357473

Brief Summary

The proposal of this study is to evaluate the association between the achievement of ongoing pregnancy and hormonal levels on the first day after the period had stopped in rec-FSH/GnRH- antagonist cycles.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2009

Status
completed

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

Study Start

First participant enrolled

November 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 20, 2011

Completed
Last Updated

May 20, 2011

Status Verified

May 1, 2011

Enrollment Period

3 months

First QC Date

May 9, 2011

Last Update Submit

May 19, 2011

Conditions

Infertility

Keywords

hormonal valuesmenstruationspregnancyantagonist

Outcome Measures

Primary Outcomes (1)

  • Ongoing pregnancy rate.

    3 months

Eligibility Criteria

Age18 Years - 37 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Infertility women treated with rec FSH/antagonist protocol

You may qualify if:

  • Body mass index between 18 and 29 kg/m²¬
  • Regular cycles between 25-34 days
  • Presence of both ovaries
  • Basal levels of estradiol (≤ 80 pg/ml) and progesterone (≤ 1.6ng/ml) on day one of the cycle
  • Treatment with IVF/ICSI
  • Embryo transfer day 3 or day 5 (1 or 2 embryos)
  • Patients can enter in the study only once

You may not qualify if:

  • Presence of endometriosis stage ≥3(AFS)
  • Polycystic ovarian syndrome (Rotterdam criteria)
  • Need for preimplantation genetic diagnosis (PGD)
  • Azoospermia testicular sperm extraction (TESE)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • DIMITRA KYROU, MD

    CRG UZ Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 9, 2011

First Posted

May 20, 2011

Study Start

November 1, 2009

Primary Completion

February 1, 2010

Study Completion

May 1, 2011

Last Updated

May 20, 2011

Record last verified: 2011-05