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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03939390

Recruitment Status Recruiting

First Posted May 6, 2019

Last update posted June 23, 2020

Study Description

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:Improving Ovarian Stimulation; Suboptimal Responders
  • Intervention/Treatment: Drug: time of administration of Corifollitropin Alfa
  • Phase: Phase 4
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • 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 2020
  • Estimated Primary Completion Date: April 2021
  • Estimated Study Completion Date: May 2021
Arms and interventions
Arm Intervention/treatment
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
  • Primary Outcome Measures: 1. number of oocytes [ Time Frame: at the end of stimulation ]
    number of oocytes after ovarian stimulation
Eligibility Criteria
  • Ages Eligible for Study: 18 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
Contacts

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

Locations

Spain
Instituto Bernabeu
Alicante

Sponsors and Collaborators

Instituto Bernabeu

More Information
  • Responsible Party: Instituto Bernabeu
  • ClinicalTrials.gov Identifier: NCT03939390 History of Changes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No