Natural Cycle/Progesterone Fortified Protocol for Endometrial Preparation for Frozen/Thawed Embryo Transfer

NCT02749344 | Completed

• 1 other identifier: 0074-15-EMC
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study of a novel protocol for preparation of the endometrium for frozen/thawed embryo transfer whereby estrogen is not administered during the proliferative phase and progesterone is administered through vaginal suppositories in accordance with endometrial thickness only, disregarding the day of ovulation. Progesterone supplementation commences once the endometrium is at least 7 mm, a follicle is demonstrated on TVS, and ovulation has not yet taken place. The day of ET is scheduled according to the unit's working days and progesterone suppositories are commenced 48 hours before the scheduled embryo transfer.

Conditions

Infertility

Keywords

Frozen Embryo Transfer, Progesterone, Endometrium

Outcome Measures

Primary Outcomes (1)

• Biochemical Pregnancy

  Positive betaHCG blood test

  14 days after embryo transfer

Secondary Outcomes (2)

• Clinical Pregnancy

  3-4 weeks after embryo transfer

• Ongoing Pregnancy

  5 weeks after embryo transfer

Study Arms (1)

FET after endometrial preparation

EXPERIMENTAL

Natural cycle/progesterone fortified endometrial preparation before embryo transfer

Other: FET after endometrial preparation

Interventions

FET after endometrial preparation OTHER

Patients included in the protocol will begin progesterone supplementation 48 hours before scheduled embryo transfer once it has been established that the endometrium is at least 7 mm and there is a leading follicle.

FET after endometrial preparation

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women younger than 39 at the time of cryopreservation
• Regular menstrual cycles of at least 26 days and at most 32 days.
• Women with no more than 3 failed prior embryo transfers
• Patients with embryos cryopreserved 48 hours after ovum pick up

You may not qualify if:

• Women with known uterine malformations or significant myomas
• Women with elevated Progesterone of at least 1.5 ng/mL for the duration of more than 72 hours before embryo transfer can be performed
• Women suspected of having endometrial pathology based on previous treatment cycles i.e. "thin endometrium", polyps, adhesions
• Women whose embryos did not survive the thawing process, i.e. no embryos available for transfer after thawing
• Women without follicular development

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Emek Medical Center

Afula, Israel

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: April 22, 2016
• Study Start: May 1, 2016
• Primary Completion: April 4, 2018
• Study Completion: April 4, 2018
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

IL (1)