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

Conventional Stimulation in Follicular Phase vs. Luteal Phase Stimulation in Patients With Suboptimal Response. Randomized Clinical Trial. SUBLUTEAL Study

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.

Study Overview

• Status: Completed
• Conditions: Improving Ovarian Stimulation; Suboptimal Responders
• Intervention / Treatment: Drug: time of administration of Corifollitropin Alfa

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03016
    • Instituto Bernabeu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 41 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of oocytes	number of oocytes after ovarian stimulation	at the end of stimulation

Collaborators and Investigators

• Sponsor: Instituto Bernabeu

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 17, 2020
• Primary Completion (ACTUAL): April 2, 2022
• Study Completion (ACTUAL): April 2, 2022

Study Registration Dates

• First Submitted: May 3, 2019
• First Submitted That Met QC Criteria: May 3, 2019
• First Posted (ACTUAL): May 6, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IB-0319-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No