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

• Sponsor: IVI Madrid (Other)
• Overall Status: Completed
• CT.gov ID: NCT01157754
• Collaborator: (none)
• Enrollment: 115
• Location: 1
• Arms: 2
• Duration (Months): 12
• Patients Per Site Per Month: 9.6

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Jun 1, 2009
• Actual Primary Completion Date: May 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. implantation rate [2 weeks after the embryo transfer]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 38 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Valenciano de Infertilidad	Madrid		Spain	28035

Sponsors and Collaborators

• IVI Madrid

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: IVI Madrid
• ClinicalTrials.gov Identifier: NCT01157754
• Other Study ID Numbers: MAD-GV-05-2009-01
• First Posted: Jul 7, 2010
• Last Update Posted: Apr 22, 2015
• Last Verified: Apr 1, 2015

• Keywords provided by IVI Madrid: Infertility patients requiring IVF; good prognosis
• Additional relevant MeSH terms: Infertility; Levonorgestrel

Study Results

No Results Posted as of Apr 22, 2015