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

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.

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.

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Study Overview

• Status: Completed
• Conditions: Female Infertility
• Intervention / Treatment: Other: LH value

• Study Type: Interventional
• Enrollment (Actual): 213
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 39 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): September 1, 2013

Study Registration Dates

• First Submitted: December 22, 2014
• First Submitted That Met QC Criteria: December 29, 2014
• First Posted (Estimate): December 31, 2014

Study Record Updates

• Last Update Posted (Estimate): December 31, 2014
• Last Update Submitted That Met QC Criteria: December 29, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female
• Other Study ID Numbers: Uospmacg