Reproductive Techniques, Assisted
Conditions
Keywords
Controlled Ovarian stimulation, Follicular phase, Luteal phase, Reproductive Techniques, Assisted
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREFollicular 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
PROCEDURELuteal 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
Sponsors
Instituto Bernabeu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Patient Bologna meets the criteria to be diagnosed as low responder * Age under 41 years * Regular menstrual cycles between 21 and 35 days * Indication of in vitro fertilization * Indication of start stimulation with 300 IU of FSH * Presence of both ovaries * Ability to participate and comply with the study protocol * Having signed the written consent form
Exclusion criteria
* Presence of follicles larger than 10 mm in the randomization visit * Endometriosis III / IV * Concomitant uterine pathology: adenomyosis, submucosal myomas, Asherman's syndrome... * Concurrent participation in another study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of oocytes in metaphase II obtained | Through study completion, average 2 weeks | number of oocytes in metaphase II obtained by follicular puncture |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| duration of stimulation (days) | Through study completion, average 2 weeks | number of days from the start of ovarian stimulation until the day of follicular puncture |
| cycle cancellation rate | Through study completion, average 2 weeks | ratio of canceled cycles regarding the number of ovarian stimulation cycles initiated |
| number of oocytes cumulus complexes | Through study completion, average 2 weeks | number of oocytes cumulus complexes obtained by follicular puncture |
| occurrence of side effects | Through study completion, average 2 weeks | occurrence of side effects at the end of study |
| fertilization rate | Through study completion, average 2 weeks | Number of correct fertilization oocytes 18 hours post-insemination |
| Luteinizing hormone levels following administration of agonist for final oocyte maturation | Through study completion, average 2 weeks | Luteinizing hormone blood levels the day after administration of agonist for final oocyte maturation |
Countries
Spain
Outcome results
None listed