NCT01157754

Brief Summary

Recent controversy has arisen regarding the use of the pill for cycle planning in GnRH antagonist IVF cycles. The investigators performed this study to compare such a protocol with the gold-standard still today, which is the long-agonist protocol with no previous use of the pill.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
115

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2009

Geographic Reach
1 country

1 active site

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

June 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 6, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 7, 2010

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

11 months

First QC Date

July 6, 2010

Last Update Submit

April 21, 2015

Conditions

Infertility

Keywords

Infertility patients requiring IVFgood prognosis

Outcome Measures

Primary Outcomes (1)

  • implantation rate

    2 weeks after the embryo transfer

Study Arms (2)

OCP+GnRH antagonist

EXPERIMENTAL

Microgynon 14 to 21 tablets starting COH on day 5 post pill, rFSH + GnRH antagonist

Drug: levonorgestrel and ethynilestradiol

long GnRH agonist

ACTIVE COMPARATOR

daily triptorelin starting day 21st of previous cycle

Drug: levonorgestrel and ethynilestradiol

Interventions

levonorgestrel and ethynilestradiolDRUG
OCP+GnRH antagonistlong GnRH agonist

Eligibility Criteria

Age18 Years - 38 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • st or 2nd IVF cycle
  • BMI \<30 kg/m2
  • regular menstrual cycles
  • basal FSH \<10 IU and E2 \<60 pg/ml

You may not qualify if:

  • Polycystic ovaries
  • endometriosis
  • previous ovarian surgery
  • previous low ovarian response

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Valenciano de Infertilidad

Madrid, Madrid, 28035, Spain

Location

MeSH Terms

Conditions

Infertility

Interventions

Levonorgestrel

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

NorgestrelNorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2010

First Posted

July 7, 2010

Study Start

June 1, 2009

Primary Completion

May 1, 2010

Study Completion

June 1, 2010

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations

ES(1)