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

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ClinicalTrials.gov Identifier: NCT02328924
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : December 31, 2014
Sponsor:
Information provided by (Responsible Party):
U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti

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.

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Condition or disease Intervention/treatment Phase
Female Infertility Other: LH value Phase 4

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Study Type : Interventional  (Clinical Trial)
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 2012
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. number of mature oocytes recruited after IVF with antagonist protocol [ Time Frame: partecipant will be followed for the duration of the cycle of IVF and for the following three months ]


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Ages Eligible for Study:   35 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

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Responsible Party: U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti
ClinicalTrials.gov Identifier: NCT02328924     History of Changes
Other Study ID Numbers: Uospmacg
First Posted: December 31, 2014    Key Record Dates
Last Update Posted: December 31, 2014
Last Verified: December 2014

Additional relevant MeSH terms:
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Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs