Basal Androgens and LH Needing for Ovarian Stimulation for in Vitro Fertilization

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Ernesto Bosch, Instituto Valenciano de Infertilidad, Spain

ClinicalTrials.gov Identifier:

NCT01563809

First received: March 22, 2012

Last updated: May 7, 2012

Last verified: May 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 22, 2012
Last Updated Date	May 7, 2012
Start Date ^ICMJE	December 2008
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 23, 2012)	Clinical Pregnancy Rate [ Time Frame: 45 days ] [ Designated as safety issue: No ] Use of rec LH supplementation for controlled ovarian stimulation for IVF
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01563809 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Basal Androgens and LH Needing for Ovarian Stimulation for in Vitro Fertilization
Official Title ^ICMJE	The Relationship Between Basal Androgen Levels and the Needing of LH for Controlled Ovarian Stimulation for in Vitro Fertilization
Brief Summary	Basing the investigators study on the evidence that basal serum androgens decrease with age, the investigators hypothesize that women with serum androgens below a certain level could be the population obtaining a benefit of Luteinizing Hormone (LH) supplementation. The objective of the present study is to explore the relationship between basal serum androgen levels and the need of LH for Controlled Ovarian Stimulation (COS) in IVF.
Detailed Description	Design: Single centre, open label, randomized controlled trial. Population: Patients with indication of In Vitro Fertilization (IVF) with the following criteria: Protocol: All patients are tested on day 3-5 of cycle for total Testosterone (Te), Dehydroepiandrosetnodione sulphate (DHEAS) and Androstenodione (Δ4). Samples are frozen and stored at -20ºC for later analysis. FSH, LH, E2, PRL and TSH are also determined. All patients follow Controlled Ovarian Stimulation for IVF with a GnRH agonist long protocol. They are randomized to receive recombinant (r) FSH alone (225 IU/day) or r-FSH + r-LH (225+75 IU/day). Sample size calculation: To detect a difference from 40 to 60% (Relative risk: 1.50) on pregnancy rate (PR) between patients with low and high androgen levels with respect to the mean of each COS protocol, with a confidence level of 95% (error α=0.05) and 80% of power (error β=0.2), 97 patients per arm were needed. (n=388 patients). Rounding up, 400 patients are to be recruited.
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Infertility
Intervention ^ICMJE	Other: No intervention No Luteinizing Hormone will be administered to this patient Drug: FSH+LH Luteinizing Hormone will be administered to this patient
Study Arm (s)	Active Comparator: Low androgens FSH+LH Intervention: Drug: FSH+LH Active Comparator: High androgens FSH+LH Intervention: Drug: FSH+LH No Intervention: High androgens FSH alone Intervention: Other: No intervention No Intervention: Low androgens, FSH alone Intervention: Other: No intervention
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	400
Completion Date	December 2010
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 1st-2nd IVF cycle Regular cycle (25-35 days) Age 18 - 42 BMI: 18-29.9 Exclusion Criteria: LH:FSH > 2 Low response background (< 5 oocytes) Recurrent pregnancy loss Preimplantational genetic diagnosis indication Any systemic, metabolic or endocrinological disorder.
Gender	Female
Ages	18 Years to 42 Years
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Spain

Administrative Information
NCT Number ^ICMJE	NCT01563809
Other Study ID Numbers ^ICMJE	0711-E-39-EB
Has Data Monitoring Committee	No
Responsible Party	Ernesto Bosch, Instituto Valenciano de Infertilidad, Spain
Study Sponsor ^ICMJE	Instituto Valenciano de Infertilidad, Spain
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Instituto Valenciano de Infertilidad, Spain
Verification Date	May 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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