Clinical trial NCT02625532: Early Follicular Phase vs Lutheal Phase Ovarian Stimulation in Bologna Criteria IVF/ICSI Cycles (LUTEAL Trial)
Official title: Early Follicular Phase vs Lutheal Phase Ovarian Stimulation in Bologna Criteria IVF/ICSI Cycles: A Randomized Comparative Single Center Trial. LUTEAL Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Reproductive Techniques, Assisted
Keywords: Controlled Ovarian stimulation
Follicular phase
Luteal phase
Reproductive Techniques, Assisted
Lead sponsor: Instituto Bernabeu
Sponsor class: OTHER
First posted: 2015-12-09
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: number of oocytes in metaphase II obtained
timeFrame: Through study completion, average 2 weeks
Secondary outcomes:
measure: number of oocytes cumulus complexes
timeFrame: Through study completion, average 2 weeks
measure: duration of stimulation (days)
timeFrame: Through study completion, average 2 weeks
measure: cycle cancellation rate
timeFrame: Through study completion, average 2 weeks
measure: Luteinizing hormone levels following administration of agonist for final oocyte maturation
timeFrame: Through study completion, average 2 weeks
measure: occurrence of side effects
timeFrame: Through study completion, average 2 weeks
measure: fertilization rate
timeFrame: Through study completion, average 2 weeks
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Instituto Bernabeu
Study officials:
affiliation: Instituto Bernabeu
name: Joaquín Llácer
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.