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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03939390

Acronym

SUBLUTEAL

Enrollment

Registered

2019-05-06

Start date

2020-01-17

Completion date

2022-04-02

Last updated

2022-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Improving Ovarian Stimulation; Suboptimal Responders

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.

Interventions

DRUGtime 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).

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 41 Years

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

Design outcomes

Primary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026