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

Female Infertility Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02328924
• Other study ID #: Uospmacg
• 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

• Female Infertility
• Infertility, Female

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