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

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. Identifier: NCT01157754
Recruitment Status : Completed
First Posted : July 7, 2010
Last Update Posted : April 22, 2015
Information provided by (Responsible Party):
IVI Madrid

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.

Condition or disease Intervention/treatment Phase
Infertility Drug: levonorgestrel and ethynilestradiol Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 115 participants
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
Study Start Date : June 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
U.S. FDA Resources

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

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

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

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

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 identifier (NCT number): NCT01157754

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

Responsible Party: IVI Madrid Identifier: NCT01157754     History of Changes
Other Study ID Numbers: MAD-GV-05-2009-01
First Posted: July 7, 2010    Key Record Dates
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:
Genital Diseases, Male
Genital Diseases, Female
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral