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CompletedNCT02328924Updated Dec 31, 2014

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

A Phase 4 interventional study of LH value in Female Infertility, sponsored by U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti. Completed. Open to female participants aged 35 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-12-31.

Sponsored by U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti · Phase 4, Interventional, and Diagnostic

Phase
Phase 4
Study type
Interventional
Enrollment
213
Allocation
Randomized
Ages
35 Years to 39 Years
Sex
Female
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Study 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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Conditions studied

  • Female Infertility
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In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 213 is above the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years to 39 Years
Sexes eligible
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

Exclusion Criteria:

  • polycystic ovaries, age >39 years
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Study design

Phase
Phase 4
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
213 participants (actual)

Study arms

  • Other
    LH value in fixed group

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

    Other: LH value

  • Other
    LH value in flexible group

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

    Other: LH value

Interventions

  • OtherLH value

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

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What researchers measure

Primary outcomes

  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

07

Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 31, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02328924
Lead sponsor
U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti
Responsible party
Sponsor
First posted
Dec 31, 2014
Start date
May 2012
Primary completion
Sep 2013
Completion
Sep 2013
Last update
Dec 31, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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