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

NCT ID: NCT06551376

Last Updated: 2024-08-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-01-31

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.

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.

Conditions

IVF

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early Follicular Phase ovarian stimulation

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

Group Type: PLACEBO_COMPARATOR

Ovarian Stimulation Start

Intervention Type: OTHER

To compare ovarian response accordin to ovarian stimualtion start

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.

Group Type: ACTIVE_COMPARATOR

Ovarian Stimulation Start

Intervention Type: OTHER

To compare ovarian response accordin to ovarian stimualtion start

Interventions

Ovarian Stimulation Start

To compare ovarian response accordin to ovarian stimualtion start

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Clinia de fertilización Asistida en el Hospital ABC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jorge Rodriguez-Purata, MD

Role: CONTACT

jorge@ovulsans.com

55 4246 9686

Other Identifiers

NPI010924

Identifier Type: -

Identifier Source: org_study_id