Status:

COMPLETED

Evaluation of Time Interval Between Ovulation Trigger With Triptorelin Acetate and Oocyte Retrieval

Lead Sponsor:

Instituto de Investigacion Sanitaria La Fe

Conditions:

Female Urogenital Diseases

Eligibility:

FEMALE

18-37 years

Phase:

PHASE2

Brief Summary

The aim of this study is to determine what is the best time interval between GnRH agonist (triptorelin acetate) ovulation induction allowing for the higher number of mature oocytes (MII) collected in ...

Detailed Description

Human chorionic gonadotrophin (hCG) has been the gold standard for ovulation induction for several decades. When GnRH antagonist protocols were introduced, it became possible to trigger final oocyte m...

Eligibility Criteria

Inclusion

  • Signed informed consent prior to carry out any procedure associated with the clinical trial.
  • Women between 18 and 37 years of age at the time of randomization (both ages included).
  • Basal serum levels of FSH \<10 mIU /ml.
  • Serum AMH \> 5 to \<45 pmol / l.
  • Antral follicle count \> 6 and \< 24.
  • Vaginal ultrasound documenting correct visualization of both ovaries and the absence of significant ovarian pathology.
  • Short stimulation protocol with GnRH antagonist and conventional dose for ovarian stimulation with 225-300 UI of rhFSH.
  • Number of follicles ≥ 16 mm \> 5 on the ovulation induction day.

Exclusion

  • Presence of severe endometriosis (Grade III-IV).
  • Absence of one ovary due to previous surgery.
  • Presence of significant uterine pathology (submucous myomas, endometrial polyp, malformations..)
  • Diagnosis of polycystic ovary syndrome (defined according to the Rotterdam criteria).
  • History of previous poor response to conventional ovarian stimulation protocols (\< 3 MII oocytes or canceled cycle)
  • Severe male factor ( TMS\< 1 million).
  • Participation in another RCT within the past one year.

Key Trial Info

Start Date :

September 1 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

February 2 2018

Estimated Enrollment :

130 Patients enrolled

Trial Details

Trial ID

NCT02244151

Start Date

September 1 2014

End Date

February 2 2018

Last Update

February 15 2018

Active Locations (1)

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Instituto de Investigacion Sanitaria La Fe

Valencia, Spain, 46026