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

This study has been completed.
Sponsor:
Information provided by:
Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01157754
First received: July 6, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Masking: Open Label
Official Title: Cycle Planning With OCP in GnRH Antagonists Cycles Versus Long Protocol in Good Prognosis IVF Patients

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • implantation rate

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 Drug: levonorgestrel and ethynilestradiol

  Eligibility

Ages Eligible for Study:   18 Years to 38 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01157754

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

No publications provided

ClinicalTrials.gov Identifier: NCT01157754     History of Changes
Other Study ID Numbers: MAD-GV-05-2009-01
Study First Received: July 6, 2010
Last Updated: July 6, 2010
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Instituto Valenciano de Infertilidad, Spain:
Infertility patients requiring IVF
good prognosis

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

ClinicalTrials.gov processed this record on May 22, 2013