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Follicular Phase Stimulation vs. Luteal Phase Stimulation in Patients Diagnosed With Suboptimal Response (SUBLUTEAL)

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ClinicalTrials.gov Identifier: NCT03939390
Recruitment Status : Recruiting
First Posted : May 6, 2019
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Joaquín Llácer, Instituto Bernabeu

Study Description
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Brief Summary:

This study aims to investigate the difference in the number of oocytes obtained by performing ovarian stimulation in follicular phase vs. luteal phase in a population of patients with previous suboptimal response.

This is a controlled randomized clinical study.

We aim to include 41 patients diagnosed with suboptimal response who will undergo an ovarian stimulation in order to vitrify and accumulate oocytes.

The main variable for evaluating the efficacy in this exploratory study will be the number of oocyte cumulus complexes obtained.


Condition or disease Intervention/treatment Phase
Improving Ovarian Stimulation; Suboptimal Responders Drug: time of administration of Corifollitropin Alfa Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Conventional Stimulation in Follicular Phase vs. Luteal Phase Stimulation in Patients With Suboptimal Response. Randomized Clinical Trial. SUBLUTEAL Study
Actual Study Start Date : January 17, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : May 30, 2021
Arms and Interventions
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Arm Intervention/treatment
No Intervention: follicular phase stimulation
Experimental: luteal phase stimulation Drug: time of administration of Corifollitropin Alfa
The treatment will be identical in both arms. The difference between the arms is the moment of the Administration of Corifollitropin Alfa: follicular phase of the menstrual cycle (control group) vs. luteal phase of the menstrual cycle (study group).


Outcome Measures
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Primary Outcome Measures :
  1. number of oocytes [ Time Frame: at the end of stimulation ]
    number of oocytes after ovarian stimulation


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 41 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets Bologna criteria to be diagnosed as poor responder
  • Less than 10 oocytes obtained in a prior controlled protocol of conventional ovarian stimulation
  • Age < 41 years
  • Body Mass Index (BMI) between 18 and 32 kg/m2
  • Regular menstrual cycles between 21 and 35 days.
  • Indication for in vitro fertilization
  • Indication to start stimulation with 150mcg of corifollitropin alpha
  • Presence of both ovaries
  • Ability to participate and comply with study protocol
  • Signing an informed consent form

Exclusion Criteria:

  • Presence of follicles larger than 10 mm in the randomization visit
  • Endometriosis stage III/IV
  • Patients with less than 4 oocytes in previous ovarian stimulation and poor ovarian reserve parameters (as per Bologna criteria)
  • 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): NCT03939390


Contacts
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Contact: Anna Pitas, PhD +34663926079 apitas@institutobernabeu.com

Locations
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Spain
Instituto Bernabeu Recruiting
Alicante, Spain, 03016
Contact: Anna Pitas, PhD    0034 663 926 079    apitas@institutobernabeu.com   
Principal Investigator: Joaquin Llacer, MD PhD         
Sponsors and Collaborators
Instituto Bernabeu
More Information
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Responsible Party: Joaquín Llácer, Dr, Instituto Bernabeu
ClinicalTrials.gov Identifier: NCT03939390    
Other Study ID Numbers: IB-0319-001
First Posted: May 6, 2019    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No