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

• Sponsor: Instituto Bernabeu (Other)
• Overall Status: Completed
• CT.gov ID: NCT03939390
• Collaborator: (none)
• Enrollment: 41
• Location: 1
• Arms: 2
• Actual Duration (Months): 26.5
• Patients Per Site Per Month: 1.5

Study Details

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

Study Design

• Study Type: Interventional
• Actual 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: Jan 17, 2020
• Actual Primary Completion Date: Apr 2, 2022
• Actual Study Completion Date: Apr 2, 2022

Arms and Interventions

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

Primary Outcome Measures

1. number of oocytes [at the end of stimulation]

   number of oocytes after ovarian stimulation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 41 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Instituto Bernabeu	Alicante		Spain	03016

Sponsors and Collaborators

• Instituto Bernabeu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jorge Sunol Sala, Dr, Instituto Bernabeu
• ClinicalTrials.gov Identifier: NCT03939390
• Other Study ID Numbers: IB-0319-001
• First Posted: May 6, 2019
• Last Update Posted: Apr 6, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 6, 2022