NCT01563809

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 22, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 27, 2012

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

2 years

First QC Date

March 22, 2012

Last Update Submit

April 21, 2015

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

  • Clinical Pregnancy Rate

    Use of rec LH supplementation for controlled ovarian stimulation for IVF

    45 days

Study Arms (4)

Low androgens FSH+LH

ACTIVE COMPARATOR

Patients with androgens below threshold receiving FSH+LH for ovarian stimulation

Drug: FSH+LH

High androgens FSH+LH

ACTIVE COMPARATOR

Patients with androgens above threshold receiving FSH+LH for ovarian stimulation

Drug: FSH+LH

High androgens FSH alone

NO INTERVENTION

Low androgens, FSH alone

NO INTERVENTION

Interventions

FSH+LHDRUG

75 IU of LH will be given from stimulation day 1

Low androgens FSH+LH

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • st-2nd IVF cycle
  • Regular cycle (25-35 days)
  • Age 18 - 42
  • BMI: 18-29.9

You may not qualify if:

  • LH:FSH \> 2
  • Low response background (\< 5 oocytes)
  • Recurrent pregnancy loss
  • Preimplantational genetic diagnosis indication
  • Any systemic, metabolic or endocrinological disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Valencia

Valencia, 46015, Spain

Location

MeSH Terms

Conditions

Infertility

Interventions

Gonadotropin-Releasing Hormone

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormone-Releasing HormonesHypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsOligopeptidesNerve Tissue ProteinsProteins

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Director IVI Valencia

Study Record Dates

First Submitted

March 22, 2012

First Posted

March 27, 2012

Study Start

December 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations

ES(1)