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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02328924
Other study ID # Uospmacg
Secondary ID
Status Completed
Phase Phase 4
First received December 22, 2014
Last updated December 29, 2014
Start date May 2012
Est. completion date September 2013

Study information

Verified date December 2014
Source U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti
Contact n/a
Is FDA regulated No
Health authority Italy: National Institute of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 213
Est. completion date September 2013
Est. primary completion date September 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 35 Years to 39 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
U.O.S. Procreazione Medicalmente Assistita e Congelamento Gameti

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
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