NCT01147770

Brief Summary

The objective of this study is to evaluate the effect of the prolongation of luteal support on the ongoing pregnancy rate (beyond 12 weeks of gestation )in recFSH/GnRH antagonist cycles.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2008

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

September 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 22, 2010

Completed
Last Updated

July 3, 2013

Status Verified

July 1, 2013

Enrollment Period

1.3 years

First QC Date

June 17, 2010

Last Update Submit

July 1, 2013

Conditions

Infertility

Keywords

progesteroneantagonistrec FSHIVFpregnancy

Outcome Measures

Primary Outcomes (1)

  • ongoing pregnancy rate

    up to 2 years

Study Arms (1)

stop progesterone

EXPERIMENTAL
Drug: progesterone

Interventions

progesteroneDRUG

duration

Also known as: utrogestan
stop progesterone

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age equal or less than 39
  • Body mass index between 18-29 kg/m2
  • Presence of both ovaries
  • Basal hormonal values on day 2 of the cycle
  • Embryotransfer day3 or day5
  • to 3 cycles

You may not qualify if:

  • Endometriosis stage 3
  • Polycystic ovarian syndrome
  • Frozen or testicular sperm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility

Interventions

ProgesteroneUtrogestan

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid Hormones

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

June 17, 2010

First Posted

June 22, 2010

Study Start

September 1, 2008

Primary Completion

January 1, 2010

Study Completion

June 1, 2010

Last Updated

July 3, 2013

Record last verified: 2013-07