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

Improving Ovarian Stimulation; Suboptimal Responders Clinical Trial

— SUBLUTEAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03939390
• Other study ID #: IB-0319-001
• Status: Completed
• Phase: Phase 4
• Start date: January 17, 2020
• Est. completion date: April 2, 2022

Study information

• Verified date: April 2022
• Source: Instituto Bernabeu
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 2, 2022
• Est. primary completion date: April 2, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 41 Years

Eligibility

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

Related Conditions & MeSH terms

• Improving Ovarian Stimulation; Suboptimal Responders

Intervention

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).

Locations

Country	Name	City	State
Spain	Instituto Bernabeu	Alicante

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Bernabeu

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of oocytes	number of oocytes after ovarian stimulation	at the end of stimulation