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

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.

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Key information

Conditions

Improving Ovarian Stimulation; Suboptimal Responders

Age range

18 year–41 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Instituto Bernabeu

Alicante, 03016, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

time of administration of Corifollitropin Alfa

Drug

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).

Primary outcomes

number of oocytes

Time frame: at the end of stimulation

number of oocytes after ovarian stimulation

Sponsors and collaborators

Lead sponsor

Instituto Bernabeu

Other

Registry information

Official study title

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

Acronym: SUBLUTEAL

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2022
First posted: May 6, 2019
Registry last updated: Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.