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

August 27, 2018 updated by: Joaquín Llácer, Instituto Bernabeu

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 03016
        • Instituto Bernabeu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Ovarian stimulation starts during the luteal phase

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Through study completion, average 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of oocytes cumulus complexes
Time Frame: Through study completion, average 2 weeks
number of oocytes cumulus complexes obtained by follicular puncture
Through study completion, average 2 weeks
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
Through study completion, average 2 weeks
cycle cancellation rate
Time Frame: Through study completion, average 2 weeks
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
Time Frame: Through study completion, average 2 weeks
Luteinizing hormone blood levels the day after administration of agonist for final oocyte maturation
Through study completion, average 2 weeks
occurrence of side effects
Time Frame: Through study completion, average 2 weeks
occurrence of side effects at the end of study
Through study completion, average 2 weeks
fertilization rate
Time Frame: Through study completion, average 2 weeks
Number of correct fertilization oocytes 18 hours post-insemination
Through study completion, average 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Bernabeu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2015

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

November 9, 2015

First Submitted That Met QC Criteria

December 6, 2015

First Posted (Estimate)

December 9, 2015

Study Record Updates

Last Update Posted (Actual)

August 29, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BER-LUT-2015-02
  • 2015-003856-31 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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