Early Follicular Phase vs Lutheal Phase Ovarian Stimulation in Bologna Criteria IVF/ICSI Cycles (LUTEAL Trial)

Instituto Bernabeu

Status

Unknown

Conditions

Reproductive Techniques, Assisted

Treatments

Procedure: Luteal phase

Procedure: Follicular phase

Study type

Interventional

Funder types

Other

Identifiers

NCT02625532

2015-003856-31 (EudraCT Number)

BER-LUT-2015-02

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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