Female Urogenital Diseases
Conditions
Keywords
ovulation induction,oocyte maturation timing and collection
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 IVF cycles.
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.
Interventions
DRUGDecapeptyl® diario
Decapeptyl® daily administration (Triptorelin acetate) and follicular puncture at 24, 30, 36 or 40 after administration.
DRUGDecapeptyl® daily
Decapeptyl® daily OPU 36 hrs after GnRH administration
Sponsors
Instituto de Investigacion Sanitaria La Fe
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 37 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of mature oocytes 40 hours post Decapeptyl administration | 40 hours post Decapeptyl administration | The trial pretends to determine the interval time needed for final oocyte maturation and ovulation after triptorelin administration. |
| Number of mature oocytes 24 hours post Decapeptyl administration | 24 hours post Decapeptyl administration | The trial pretends to determine the interval time needed for final oocyte maturation and ovulation after triptorelin administration. |
| Number of mature oocytes 30 hours post Decapeptyl administration | 30 hours post Decapeptyl administration | The trial pretends to determine the interval time needed for final oocyte maturation and ovulation after triptorelin administration. |
| Number of mature oocytes 36 hours post Decapeptyl administration | 36 hours post Decapeptyl administration | The trial pretends to determine the interval time needed for final oocyte maturation and ovulation after triptorelin administration. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum and follicular fluid levels of Amphiregulin (AR) and Epiregulin | 24, 30, 36 and 40 hours post Decapeptyl administration | Serum and follicular fluid levels of Amphiregulin (AR) and Epiregulin |
| 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 | Serum and follicular fluid hormonal levels (estradiol , LH and progesterone) |
| Total number of follicles > 16 mm punctured. | Time 0 (when Decapeptyl administration) | Total number of follicles \> 16 mm punctured. |
| Total number of oocytes retrieved | 24, 30, 36 and 40 hours post Decapeptyl administration | Total number of oocytes retrieved |
Countries
Spain
Outcome results
None listed