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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01157754
First Posted: July 7, 2010
Last Update Posted: April 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
IVI Madrid
  Purpose
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.

Condition Intervention
Infertility Drug: levonorgestrel and ethynilestradiol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cycle Planning With OCP in GnRH Antagonists Cycles Versus Long Protocol in Good Prognosis IVF Patients

Resource links provided by NLM:


Further study details as provided by IVI Madrid:

Primary Outcome Measures:
  • implantation rate [ Time Frame: 2 weeks after the embryo transfer ]

Enrollment: 115
Study Start Date: June 2009
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01157754


Locations
Spain
Instituto Valenciano de Infertilidad
Madrid, Spain, 28035
Sponsors and Collaborators
IVI Madrid
  More Information

Responsible Party: IVI Madrid
ClinicalTrials.gov Identifier: NCT01157754     History of Changes
Other Study ID Numbers: MAD-GV-05-2009-01
First Submitted: July 6, 2010
First Posted: July 7, 2010
Last Update Posted: April 22, 2015
Last Verified: April 2015

Keywords provided by IVI Madrid:
Infertility patients requiring IVF
good prognosis

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral