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Completed

NCT Number: NCT02244151

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

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.

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Key information

Age range

18 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Instituto de Investigacion Sanitaria La Fe

Valencia, 46026, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Decapeptyl® diario

Drug

Decapeptyl® daily administration (Triptorelin acetate) and follicular puncture at 24, 30, 36 or 40 after administration.

Other names: Decapeptyl® daily; GnRHa

Decapeptyl® daily

Drug

Decapeptyl® daily OPU 36 hrs after GnRH administration

Other names: Decapeptyl® diario; GnRHa

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. Total number of follicles > 16 mm punctured.

    Time frame: Time 0 (when Decapeptyl administration)

    Total number of follicles > 16 mm punctured.

  2. Total number of oocytes retrieved

    Time frame: 24, 30, 36 and 40 hours post Decapeptyl administration

    Total number of oocytes retrieved

  3. 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

  4. 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)

Sponsors and collaborators

Lead sponsor

Instituto de Investigacion Sanitaria La Fe

Other

Registry information

Official study title

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

Acronym: TIMING

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Sep 18, 2014
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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