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

Female Urogenital Diseases Clinical Trial

— TIMING  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02244151
• Other study ID #: TIMING
• Secondary ID: 2012-005571-14
• Status: Completed
• Phase: Phase 2
• First received: June 17, 2014
• Last updated: February 14, 2018
• Start date: September 2014
• Est. completion date: February 2, 2018

Study information

• Verified date: August 2017
• Source: Instituto de Investigacion Sanitaria La Fe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 IVF cycles.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: February 2, 2018
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 37 Years

Eligibility

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.

Related Conditions & MeSH terms

• Female Urogenital Diseases

Intervention

Drug:
• Decapeptyl® diario
Decapeptyl® daily administration (Triptorelin acetate) and follicular puncture at 24, 30, 36 or 40 after administration.
• Decapeptyl® daily
Decapeptyl® daily OPU 36 hrs after GnRH administration

Locations

Country	Name	City	State
Spain	Instituto de Investigacion Sanitaria La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigacion Sanitaria La Fe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of mature oocytes 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
Primary	Number of mature oocytes 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
Primary	Number of mature oocytes 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
Primary	Number of mature oocytes 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	Total number of follicles > 16 mm punctured.	Total number of follicles > 16 mm punctured.	Time 0 (when Decapeptyl administration)
Secondary	Total number of oocytes retrieved	Total number of oocytes retrieved	24, 30, 36 and 40 hours post Decapeptyl administration
Secondary	Serum and follicular fluid levels of Amphiregulin (AR) and Epiregulin	Serum and follicular fluid levels of Amphiregulin (AR) and Epiregulin	24, 30, 36 and 40 hours post Decapeptyl administration
Secondary	Serum and follicular fluid hormonal levels (estradiol , LH and progesterone)	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