An interventional study of Follicular phase and Luteal phase in Reproductive Techniques, Assisted, sponsored by Instituto Bernabeu. Status unknown at 1 site in Spain. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-29.
Sponsored by Instituto Bernabeu · Not applicable, Interventional, and Treatment
Exploratory, prospective, randomized, comparative, open trial with control group treated to assess the efficacy of follicular phase ovarian stimulation compared to lutheal phase ovarian stimulation in women with Bologna criteria for poor ovarian response.
Two arms is established, the study group that will start ovarian stimulation in the luteal phase and the control group that will start ovarian stimulation in the follicular phase.
The randomization will be made in the 2-3 day of the menstrual cycle, according to a list of random allocation of treatments. After check that there is no contraindication to start the stimulation, the patients will be assigned to the treatment group.
The patients in the control group (follicular phase group) will start stimulation with two vials of 150 IU recombinant FSH + 75 IU recombinant LH (Pergoveris® 150/75). The patients in the study group (luteal phase group) will perform daily urine LH test from day 7th of the cycle and will start the administration of 150 IU recombinant FSH + 75 IU recombinant LH (Pergoveris® 150/75) at two vials daily from the 4th day of the LH positive test.
Antagonist cetrorelix acetate (Cetrotide® ) administration will start when the largest follicle shall be equal or greater than 14 mm. From this moment controls every 24-72 hours with foliculometría by ultrasound and blood hormone analysis with determination of estradiol and progesterone. For the final oocyte maturation 2 vials daily of 0.2 mg triptorelin acetate (Decapeptyl®) is administered. Oocyte collection will be made by transvaginal ultrasound-guided puncture according to IB protocol
The dosages and protocols used will be the usual for patients with diagnostic of poor ovarian response.
Instituto Bernabeu is the lead sponsor of 18 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Controlled ovarian stimulation starts during follicular phase on day 2-3 of the menstrual cycle
Procedure: Follicular phase
Controlled ovarian stimulation starts during luteal phase on day 3 to 5 after first LH positive urine test
Procedure: Luteal phase
Controlled ovarian stimulation starts on day 2-3 of the menstrual cycle with recombinant recombinant FSH + LH, adding cetrorelix when the follicles reach 14 mm size and ovarian maturation with triptorelin acetate
Also known as: Ovarian stimulation starts during the follicular phase
Controlled ovarian stimulation is started between 3rd and 5th day after the first LH positive urine test, adding cetrorelix when follicles reached 14 mm size and ovarian maturation with triptorelin acetate
Also known as: Ovarian stimulation starts during the luteal phase
number of oocytes in metaphase II obtained
number of oocytes in metaphase II obtained by follicular puncture
Time frame: Through study completion, average 2 weeks
number of oocytes cumulus complexes
number of oocytes cumulus complexes obtained by follicular puncture
Time frame: Through study completion, average 2 weeks
duration of stimulation (days)
number of days from the start of ovarian stimulation until the day of follicular puncture
Time frame: Through study completion, average 2 weeks
cycle cancellation rate
ratio of canceled cycles regarding the number of ovarian stimulation cycles initiated
Time frame: Through study completion, average 2 weeks
Luteinizing hormone levels following administration of agonist for final oocyte maturation
Luteinizing hormone blood levels the day after administration of agonist for final oocyte maturation
Time frame: Through study completion, average 2 weeks
occurrence of side effects
occurrence of side effects at the end of study
Time frame: Through study completion, average 2 weeks
fertilization rate
Number of correct fertilization oocytes 18 hours post-insemination
Time frame: Through study completion, average 2 weeks
This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Instituto Bernabeu