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

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ClinicalTrials.gov Identifier: NCT02625532
Recruitment Status : Active, not recruiting
First Posted : December 9, 2015
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
Joaquín Llácer, Instituto Bernabeu

Study Description
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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.

Condition or disease Intervention/treatment Phase
Reproductive Techniques, Assisted Procedure: Follicular phase Procedure: Luteal phase Not Applicable

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Early Follicular Phase vs Lutheal Phase Ovarian Stimulation in Bologna Criteria IVF/ICSI Cycles: A Randomized Comparative Single Center Trial. LUTEAL Trial
Actual Study Start Date : December 2015
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : January 2019
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Follicular phase
Controlled ovarian stimulation starts during follicular phase on day 2-3 of the menstrual cycle
 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
Other Name: Ovarian stimulation starts during the follicular phase
Experimental: Luteal phase
Controlled ovarian stimulation starts during luteal phase on day 3 to 5 after first LH positive urine test
 Procedure: 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
Other Name: Ovarian stimulation starts during the luteal phase


Outcome Measures
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Primary Outcome Measures :
  1. number of oocytes in metaphase II obtained [ Time Frame: Through study completion, average 2 weeks ]
    number of oocytes in metaphase II obtained by follicular puncture


Secondary Outcome Measures :
  1. number of oocytes cumulus complexes [ Time Frame: Through study completion, average 2 weeks ]
    number of oocytes cumulus complexes obtained by follicular puncture

  2. duration of stimulation (days) [ Time Frame: Through study completion, average 2 weeks ]
    number of days from the start of ovarian stimulation until the day of follicular puncture

  3. cycle cancellation rate [ Time Frame: Through study completion, average 2 weeks ]
    ratio of canceled cycles regarding the number of ovarian stimulation cycles initiated

  4. Luteinizing hormone levels following administration of agonist for final oocyte maturation [ Time Frame: Through study completion, average 2 weeks ]
    Luteinizing hormone blood levels the day after administration of agonist for final oocyte maturation

  5. occurrence of side effects [ Time Frame: Through study completion, average 2 weeks ]
    occurrence of side effects at the end of study

  6. fertilization rate [ Time Frame: Through study completion, average 2 weeks ]
    Number of correct fertilization oocytes 18 hours post-insemination


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02625532


Locations
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Spain
Instituto Bernabeu
Alicante, Spain, 03016
Sponsors and Collaborators
Instituto Bernabeu
Investigators
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Principal Investigator: Joaquín Llácer Instituto Bernabeu
More Information
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Responsible Party: Joaquín Llácer, Gynaecologist. Reproductive Medicine Specialist at Instituto Bernabeu, Instituto Bernabeu
ClinicalTrials.gov Identifier: NCT02625532     History of Changes
Other Study ID Numbers: BER-LUT-2015-02
2015-003856-31 ( EudraCT Number )
First Posted: December 9, 2015    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018
Keywords provided by Joaquín Llácer, Instituto Bernabeu:
Controlled Ovarian stimulation
Follicular phase
Luteal phase
Reproductive Techniques, Assisted