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

Instituto Bernabeu

Status and phase

Completed

Phase 4

Conditions

Improving Ovarian Stimulation; Suboptimal Responders

Treatments

Drug: time of administration of Corifollitropin Alfa

Study type

Interventional

Funder types

Other

Identifiers

NCT03939390

IB-0319-001

Details and patient eligibility

About

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.

Enrollment

41 patients

Sex

Female

Ages

18 to 41 years old

Volunteers

No Healthy Volunteers

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