Oral Contraceptive Pill and GnRH Antagonist Versus Long Protocol in IVF Patients (Larganta)

April 21, 2015 updated by: IVI Madrid

Cycle Planning With OCP in GnRH Antagonists Cycles Versus Long Protocol in Good Prognosis IVF Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28035
        • Instituto Valenciano de Infertilidad

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 38 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 1st or 2nd IVF cycle
  • BMI <30 kg/m2
  • regular menstrual cycles
  • basal FSH <10 IU and E2 <60 pg/ml

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: OCP+GnRH antagonist
Microgynon 14 to 21 tablets starting COH on day 5 post pill, rFSH + GnRH antagonist
Drug: levonorgestrel and ethynilestradiol
ACTIVE_COMPARATOR: long GnRH agonist
daily triptorelin starting day 21st of previous cycle
Drug: levonorgestrel and ethynilestradiol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
implantation rate
Time Frame: 2 weeks after the embryo transfer
2 weeks after the embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IVI Madrid

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ACTUAL)

May 1, 2010

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

July 6, 2010

First Submitted That Met QC Criteria

July 6, 2010

First Posted (ESTIMATE)

July 7, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

April 22, 2015

Last Update Submitted That Met QC Criteria

April 21, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAD-GV-05-2009-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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