There is a Value of Luteinizing Hormone Predictive of in Vitro Fertilization Treatment Outcome in Antagonist Protocols?

Sponsor

U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti (Other)

Overall Status

Completed

CT.gov ID

NCT02328924

Collaborator

(none)

213

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Female Infertility	Other: LH value	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

213 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

There is a Cut Off Value of Luteinizing Hormone Predictive of in Vitro Fertilization Treatment Outcome? A Randomized Controlled Trial in Fixed Versus Flexible Gonadotropin-releasing Hormone Antagonist Protocols.

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Sep 1, 2013

Actual Study Completion Date :

Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: LH value in fixed group LH value predictive of IVF in 104 patients entered in fixed protocol	Other: LH value analyzed LH value in the the arms of the study, fixed and flexible protocols
Other: LH value in flexible group LH value predictive of IVF in 109 patients entered in flexible protocols	Other: LH value analyzed LH value in the the arms of the study, fixed and flexible protocols

Arm

Intervention/Treatment

Other: LH value in fixed group

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

Other: LH value

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

Other: LH value in flexible group

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

Other: LH value

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

1. 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

Exclusion Criteria:

polycystic ovaries, age >39 years

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti

ClinicalTrials.gov Identifier:

NCT02328924

Other Study ID Numbers:

Uospmacg

First Posted:

Dec 31, 2014

Last Update Posted:

Dec 31, 2014

Last Verified:

Dec 1, 2014

Additional relevant MeSH terms:

Infertility

Infertility, Female

Study Results

No Results Posted as of Dec 31, 2014