Instituto de Investigacion Sanitaria La Fe
Valencia, 46026, Spain
NCT Number: NCT02244151
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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Notify Me18 year–37 year
Female
Interventional
Phase 2
Valencia, 46026, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Basal serum levels of FSH <10 mIU /ml.
Exclusion criteria
Decapeptyl® daily administration (Triptorelin acetate) and follicular puncture at 24, 30, 36 or 40 after administration.
Other names: Decapeptyl® daily; GnRHa
Decapeptyl® daily OPU 36 hrs after GnRH administration
Other names: Decapeptyl® diario; GnRHa
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.
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.
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.
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.
Time frame: Time 0 (when Decapeptyl administration)
Total number of follicles > 16 mm punctured.
Time frame: 24, 30, 36 and 40 hours post Decapeptyl administration
Total number of oocytes retrieved
Time frame: 24, 30, 36 and 40 hours post Decapeptyl administration
Serum and follicular fluid levels of Amphiregulin (AR) and Epiregulin
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)
Instituto de Investigacion Sanitaria La Fe
Other
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
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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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