NCT06551376

Brief Summary

To compare cycle outcomes after scheduling with the standard early follicular phase (EFP) versus late luteal phase (LLP) in patients undergoing GnRH antagonist cycles.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

5 months

First QC Date

August 9, 2024

Last Update Submit

August 9, 2024

Conditions

IVF

Keywords

Ovarian Stimulationluteal phase startearly follicular phase startovarian response

Outcome Measures

Primary Outcomes (1)

  • mature oocytes retrieved

    At retrieval

Secondary Outcomes (3)

  • fertilization rate

    24 hours after retrieval

  • viable embryo rate per oocyte retrieved

    5 days after retrieval

  • cancellation rate

    14 days after cycle start

Study Arms (2)

Early Follicular Phase ovarian stimulation

PLACEBO COMPARATOR

Twenty patients started controlled ovarian stimulation (COS) after spontaneous menses

Other: Ovarian Stimulation Start

Late Luteal Phase ovarian stimulation

ACTIVE COMPARATOR

Twenty patients started stimulation on the Friday previous to a spontaneous menses (at the end of late luteal phase), regardless of cycle day.

Other: Ovarian Stimulation Start

Interventions

Ovarian Stimulation StartOTHER

To compare ovarian response accordin to ovarian stimualtion start

Early Follicular Phase ovarian stimulationLate Luteal Phase ovarian stimulation

Eligibility Criteria

Age20 Years - 42 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Regularly cycling women aged ≤40 years with fewer than one previous IVF attempts were enrolled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Jorge Rodriguez-Purata, MD

CONTACT

55 4246 9686jorge@ovulsans.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2024

First Posted

August 13, 2024

Study Start

September 1, 2024

Primary Completion

January 31, 2025

Study Completion

January 31, 2025

Last Updated

August 13, 2024

Record last verified: 2024-08