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

NCT03939390 | Completed Phase 4

• 1 other identifier: IB-0319-001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Improving Ovarian Stimulation; Suboptimal Responders

Outcome Measures

Primary Outcomes (1)

• number of oocytes

  number of oocytes after ovarian stimulation

  at the end of stimulation

Study Arms (2)

follicular phase stimulation

NO INTERVENTION

luteal phase stimulation

EXPERIMENTAL

Drug: time of administration of Corifollitropin Alfa

Interventions

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).

luteal phase stimulation

Eligibility Criteria

• Age: 18 Years - 41 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto Bernabeu: lead

Study Sites (1)

Instituto Bernabeu

Alicante, 03016, Spain

Location

Related Publications (1)

• 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.

  PMID: 38204945 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 6, 2019
• Study Start: January 17, 2020
• Primary Completion: April 2, 2022
• Study Completion: April 2, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-04

Locations

ES (1)