NCT02328924

Brief Summary

This study, prospective randomized controlled trial, tried to identify a cut off value of luteinizing hormone predictive of in vitro fertilization outcome in a fixed or flexible gonadotropin-releasing hormone antagonist protocols. 202 norma-ovulatory women \< 39 years were randomized to fixed or flexible group in GnRH antagonist protocols The follicular phase profile of luteinizing hormone, estradiol and progesterone in the two study groups was measured. Total number of retrieved oocytes, implantation and pregnancy rate were recorded. .

Trial Health

100
On Track

Trial Health Score

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

Enrollment
213

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2012

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
Last Updated

December 31, 2014

Status Verified

December 1, 2014

Enrollment Period

1.3 years

First QC Date

December 22, 2014

Last Update Submit

December 29, 2014

Conditions

Female Infertility

Outcome Measures

Primary Outcomes (1)

  • number of mature oocytes recruited after IVF with antagonist protocol

    partecipant will be followed for the duration of the cycle of IVF and for the following three months

Study Arms (2)

LH value in fixed group

OTHER

LH value predictive of IVF in 104 patients entered in fixed protocol

Other: LH value

LH value in flexible group

OTHER

LH value predictive of IVF in 109 patients entered in flexible protocols

Other: LH value

Interventions

LH valueOTHER

analyzed LH value in the the arms of the study, fixed and flexible protocols

LH value in fixed groupLH value in flexible group

Eligibility Criteria

Age35 Years - 39 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \) age \<39 years; (2) normal menstrual cycle (range of 26-32 days); (3) baseline follicle stimulating hormone levels \< 12 IU/ml; (4) body mass index (BMI) between 18-30 Kg/m2; (5) no oral contraceptive pills taken in the last year

You may not qualify if:

  • polycystic ovaries, age \>39 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2014

First Posted

December 31, 2014

Study Start

May 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

December 31, 2014

Record last verified: 2014-12