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

February 14, 2018 updated by: Instituto de Investigacion Sanitaria La Fe

Evaluation of the Time Interval Between Ovulation Trigger With Triptorelin Acetate and Oocyte Retrieval in IVF Cycles: A Simple Blind, Randomized Controlled Trial.

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 IVF cycles.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 maturation and ovulation with a single bolus of a GnRH agonist (GnRHa) as an alternative to hCG. The use of GnRHa to trigger final oocyte maturation has potential advantages: the simultaneous induction of a FSH surge, higher numbers of mature oocytes retrieved as compared to hCG and the total elimination of ovarian hyperstimulation syndrome.

From the earliest reports of GnRHa for ovulation triggering, it has been presumed that the timing of the ovum pick-up (OPU) after GnRHa administration should be the same as after hCG triggering (34-36 h). However, differences exist regarding the duration and profile of the GnRHa induced surge of gonadotrophins when compared with that of hCG. Even more, differences in the intra-follicular mechanisms involved in ovulation have been described after GnRHa and hCG trigger.

No previous randomized controlled trials have been reported to evaluate the optimal interval of time between ovulation induction by GnRHa and oocyte collection.

The present study compares the ovarian response and the IVF outcomes after induction by triptorelin 0.2 mg at four different time intervals:

Group 1: OPU 24 hours after GnRHa administration. Group 2: OPU 30 hours after GnRHa administration. Group 3: OPU 40 hours after GnRHa administration. Group 4: control group: OPU 36 hours after GnRHa administration.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46026
        • Instituto de Investigacion Sanitaria La Fe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DECAPEPTYL® diario
Group 1: DECAPEPTYL® diario,OPU 24 hours after GnRHa administration.
Drug: Decapeptyl® diario
Decapeptyl® daily administration (Triptorelin acetate) and follicular puncture at 24, 30, 36 or 40 after administration.
Other Names:
  • Decapeptyl® daily; GnRHa
Experimental: Decapeptyl® diaro
Group 2:Decapeptyl® diario OPU 30 hours after GnRHa administration.
Drug: Decapeptyl® diario
Decapeptyl® daily administration (Triptorelin acetate) and follicular puncture at 24, 30, 36 or 40 after administration.
Other Names:
  • Decapeptyl® daily; GnRHa
Experimental: Decapeptyl® diario.
Group 3: Decapeptyl® diario, OPU 40 hours after GnRHa administration.
Drug: Decapeptyl® diario
Decapeptyl® daily administration (Triptorelin acetate) and follicular puncture at 24, 30, 36 or 40 after administration.
Other Names:
  • Decapeptyl® daily; GnRHa
Active Comparator: Decapeptyl® daily
Group 4: Decapeptyl® daily OPU 36 hrs after GnRH administration
Drug: Decapeptyl® daily
Decapeptyl® daily OPU 36 hrs after GnRH administration
Other Names:
  • Decapeptyl® diario; GnRHa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of mature oocytes 24 hours post Decapeptyl administration
Time Frame: 24 hours post Decapeptyl administration
The trial pretends to determine the interval time needed for final oocyte maturation and ovulation after triptorelin administration.
24 hours post Decapeptyl administration
Number of mature oocytes 30 hours post Decapeptyl administration
Time Frame: 30 hours post Decapeptyl administration
The trial pretends to determine the interval time needed for final oocyte maturation and ovulation after triptorelin administration.
30 hours post Decapeptyl administration
Number of mature oocytes 36 hours post Decapeptyl administration
Time Frame: 36 hours post Decapeptyl administration
The trial pretends to determine the interval time needed for final oocyte maturation and ovulation after triptorelin administration.
36 hours post Decapeptyl administration
Number of mature oocytes 40 hours post Decapeptyl administration
Time Frame: 40 hours post Decapeptyl administration
The trial pretends to determine the interval time needed for final oocyte maturation and ovulation after triptorelin administration.
40 hours post Decapeptyl administration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total number of follicles > 16 mm punctured.
Time Frame: Time 0 (when Decapeptyl administration)
Total number of follicles > 16 mm punctured.
Time 0 (when Decapeptyl administration)
Total number of oocytes retrieved
Time Frame: 24, 30, 36 and 40 hours post Decapeptyl administration
Total number of oocytes retrieved
24, 30, 36 and 40 hours post Decapeptyl administration
Serum and follicular fluid levels of Amphiregulin (AR) and Epiregulin
Time Frame: 24, 30, 36 and 40 hours post Decapeptyl administration
Serum and follicular fluid levels of Amphiregulin (AR) and Epiregulin
24, 30, 36 and 40 hours post Decapeptyl administration
Serum and follicular fluid hormonal levels (estradiol , LH and progesterone)
Time Frame: Time 0 (when Decapeptyl administration) , 12 hours after Decapeptyl administration , OPU moment and day of embryo transfer
Serum and follicular fluid hormonal levels (estradiol , LH and progesterone)
Time 0 (when Decapeptyl administration) , 12 hours after Decapeptyl administration , OPU moment and day of embryo transfer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigacion Sanitaria La Fe

Investigators

  • Principal Investigator: Alicia Marzal, M.D, Grupo de Investigación en Medicina Reproductiva, IIS La Fe, Valencia ; Spain
  • Study Chair: César Díaz-García, M.D, Unidad de Reproducción Humana, Area de Salud de la Mujer, Hospital Universitaria La Fe, Valencia, Spain. Grupo de Investigación en Medicina Reproductiva, IIS La Fe, Valencia ; Spain
  • Study Director: Antonio Pellicer, Professor, Unidad de Reproducción Humana, Area de Salud de la Mujer, Hospital Universitaria La Fe, Valencia, Spain. Grupo de Investigación en Medicina Reproductiva, IIS La Fe, Valencia ; Spain.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

February 1, 2018

Study Completion (Actual)

February 2, 2018

Study Registration Dates

First Submitted

June 17, 2014

First Submitted That Met QC Criteria

September 16, 2014

First Posted (Estimate)

September 18, 2014

Study Record Updates

Last Update Posted (Actual)

February 15, 2018

Last Update Submitted That Met QC Criteria

February 14, 2018

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TIMING
  • 2012-005571-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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