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

NCT ID: NCT03939390

Last Updated: 2022-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-17

Study Completion Date

2022-04-02

Brief Summary

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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.

Detailed Description

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Conditions

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Improving Ovarian Stimulation; Suboptimal Responders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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follicular phase stimulation

Group Type NO_INTERVENTION

No interventions assigned to this group

luteal phase stimulation

Group Type EXPERIMENTAL

time of administration of Corifollitropin Alfa

Intervention Type 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).

Interventions

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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).

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

41 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Instituto Bernabeu

OTHER

Sponsor Role lead

Responsible Party

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Jorge Sunol Sala

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Instituto Bernabeu

Alicante, , Spain

Site Status

Countries

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Spain

References

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Sunol J, Castillo JC, Ortiz JA, Ten J, Fuentes A, Moliner B, Martinez M, Llacer J, Guerrero J, Pitas A, Bernabeu A, Bernabeu R. Conventional follicular-phase ovarian stimulation vs. luteal-phase stimulation in suboptimal responders: a randomized controlled trial. F S Rep. 2023 Jul 27;4(4):344-352. doi: 10.1016/j.xfre.2023.07.003. eCollection 2023 Dec.

Reference Type DERIVED
PMID: 38204945 (View on PubMed)

Other Identifiers

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IB-0319-001

Identifier Type: -

Identifier Source: org_study_id

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