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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003856-31 | EudraCT Number |
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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 foliculometrÃa 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Follicular phase | Active Comparator | Controlled ovarian stimulation starts during follicular phase on day 2-3 of the menstrual cycle |
|
| Luteal phase | Experimental | Controlled ovarian stimulation starts during luteal phase on day 3 to 5 after first LH positive urine test |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Follicular phase | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| number of oocytes in metaphase II obtained | number of oocytes in metaphase II obtained by follicular puncture | Through study completion, average 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| number of oocytes cumulus complexes | number of oocytes cumulus complexes obtained by follicular puncture | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| JoaquÃn Llácer | Instituto Bernabeu | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto Bernabeu | Alicante | 03016 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32033610 | Derived | Llacer J, Moliner B, Luque L, Bernabeu A, Lledo B, Castillo JC, Guerrero J, Ten J, Bernabeu R. Luteal phase stimulation versus follicular phase stimulation in poor ovarian responders: results of a randomized controlled trial. Reprod Biol Endocrinol. 2020 Feb 7;18(1):9. doi: 10.1186/s12958-020-00570-7. |
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| ID | Term |
|---|---|
| D006379 | Helping Behavior |
| ID | Term |
|---|---|
| D012919 | Social Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D005498 | Follicular Phase |
| D008183 | Luteal Phase |
| ID | Term |
|---|---|
| D008597 | Menstrual Cycle |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
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| Luteal phase | Procedure | 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 |
|
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| Through study completion, average 2 weeks |
| cycle cancellation rate | ratio of canceled cycles regarding the number of ovarian stimulation cycles initiated | 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 | Through study completion, average 2 weeks |
| occurrence of side effects | occurrence of side effects at the end of study | Through study completion, average 2 weeks |
| fertilization rate | Number of correct fertilization oocytes 18 hours post-insemination | Through study completion, average 2 weeks |