LATE LUTEAL PHASE VS. CONVENTIONAL EARLY FOLLICULAR PHASE START IN IVF

August 9, 2024 updated by: Clinia de fertilización Asistida en el Hospital ABC

IVF CYCLE SCHEDULING WITH LATE LUTEAL PHASE VS. CONVENTIONAL EARLY FOLLICULAR PHASE START TO AVOID WEEKENDS RETRIEVALS: PROOF OF CONCEPT

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Design Multicentric prospective non-randomized study

Setting Two university-affiliated private assisted reproduction centers.

Patient(s) Regularly cycling women aged ≤40 years with fewer than one previous IVF attempts were enrolled. Previous low responses to controlled ovarian hyperstimulation, ovarian surgery, or polycystic ovary were exclusion criteria.

Intervention(s) Twenty patients started controlled ovarian stimulation (COS) after spontaneous menses; similarly, twenty patients started stimulation on the Friday previous to a spontaneous menses (at the end of late luteal phase), regardless of cycle day.

Main Outcome Measure(s) Primary outcome: number of mature oocytes retrieved. Secondary outcomes: fertilization rate, viable embryo rate per oocyte retrieved, cancellation rate, and clinical pregnancy outcomes from FET cycles.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Previous low responses to controlled ovarian hyperstimulation, ovarian surgery, or polycystic ovary were exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Early Follicular Phase ovarian stimulation
Twenty patients started controlled ovarian stimulation (COS) after spontaneous menses
Other: Ovarian Stimulation Start
To compare ovarian response accordin to ovarian stimualtion start
Active Comparator: Late Luteal Phase ovarian stimulation
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
To compare ovarian response accordin to ovarian stimualtion start

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mature oocytes retrieved
Time Frame: At retrieval
At retrieval

Secondary Outcome Measures

Outcome Measure
Time Frame
fertilization rate
Time Frame: 24 hours after retrieval
24 hours after retrieval
viable embryo rate per oocyte retrieved
Time Frame: 5 days after retrieval
5 days after retrieval
cancellation rate
Time Frame: 14 days after cycle start
14 days after cycle start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinia de fertilización Asistida en el Hospital ABC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

January 31, 2025

Study Registration Dates

First Submitted

August 9, 2024

First Submitted That Met QC Criteria

August 9, 2024

First Posted (Actual)

August 13, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 9, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NPI010924

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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