Basal Androgens and LH Needing for Ovarian Stimulation for in Vitro Fertilization
Primary Purpose
Infertility
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
FSH+LH
FSH+LH
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility Criteria
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.
Sites / Locations
- IVI Valencia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
No Intervention
No Intervention
Arm Label
Low androgens FSH+LH
High androgens FSH+LH
High androgens FSH alone
Low androgens, FSH alone
Arm Description
Patients with androgens below threshold receiving FSH+LH for ovarian stimulation
Patients with androgens above threshold receiving FSH+LH for ovarian stimulation
Outcomes
Primary Outcome Measures
Clinical Pregnancy Rate
Use of rec LH supplementation for controlled ovarian stimulation for IVF
Secondary Outcome Measures
Full Information
NCT ID
NCT01563809
First Posted
March 22, 2012
Last Updated
April 21, 2015
Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
1. Study Identification
Unique Protocol Identification Number
NCT01563809
Brief Title
Basal Androgens and LH Needing for Ovarian Stimulation for in Vitro Fertilization
Official Title
The Relationship Between Basal Androgen Levels and the Needing of LH for Controlled Ovarian Stimulation for in Vitro Fertilization
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low androgens FSH+LH
Arm Type
Active Comparator
Arm Description
Patients with androgens below threshold receiving FSH+LH for ovarian stimulation
Arm Title
High androgens FSH+LH
Arm Type
Active Comparator
Arm Description
Patients with androgens above threshold receiving FSH+LH for ovarian stimulation
Arm Title
High androgens FSH alone
Arm Type
No Intervention
Arm Title
Low androgens, FSH alone
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
FSH+LH
Intervention Description
75 IU of LH will be given from stimulation day 1
Intervention Type
Drug
Intervention Name(s)
FSH+LH
Intervention Description
75 IU of LH will be given from stimulation day 1
Primary Outcome Measure Information:
Title
Clinical Pregnancy Rate
Description
Use of rec LH supplementation for controlled ovarian stimulation for IVF
Time Frame
45 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
IVI Valencia
City
Valencia
ZIP/Postal Code
46015
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Basal Androgens and LH Needing for Ovarian Stimulation for in Vitro Fertilization
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