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

Reproductive Techniques, Assisted Clinical Trial

— LUTEAL  

Official title:

Early Follicular Phase vs Lutheal Phase Ovarian Stimulation in Bologna Criteria IVF/ICSI Cycles: A Randomized Comparative Single Center Trial. LUTEAL Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02625532
• Other study ID #: BER-LUT-2015-02
• Secondary ID: 2015-003856-31
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 2015
• Est. completion date: January 2019

Study information

• Verified date: August 2018
• Source: Instituto Bernabeu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: January 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Reproductive Techniques, Assisted

Intervention

Procedure:
• Follicular 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
• Luteal 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

Locations

Country	Name	City	State
Spain	Instituto Bernabeu	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Bernabeu

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of oocytes in metaphase II obtained	number of oocytes in metaphase II obtained by follicular puncture	Through study completion, average 2 weeks
Secondary	number of oocytes cumulus complexes	number of oocytes cumulus complexes obtained by follicular puncture	Through study completion, average 2 weeks
Secondary	duration of stimulation (days)	number of days from the start of ovarian stimulation until the day of follicular puncture	Through study completion, average 2 weeks
Secondary	cycle cancellation rate	ratio of canceled cycles regarding the number of ovarian stimulation cycles initiated	Through study completion, average 2 weeks
Secondary	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
Secondary	occurrence of side effects	occurrence of side effects at the end of study	Through study completion, average 2 weeks
Secondary	fertilization rate	Number of correct fertilization oocytes 18 hours post-insemination	Through study completion, average 2 weeks