CycloCT: Progesterone Levels and Clinical Outcomes Using a Single Pessary of 400 mg of Vaginal Progesterone in Substitutive Cycles for Embryo Transfer.

Sponsor

Instituto Bernabeu (Other)

Overall Status

Completed

CT.gov ID

NCT04722471

Collaborator

(none)

347

Enrollment

Location

Actual Duration (Days)

754.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to compare the efficacy, in terms of progesterone levels and clinical outcomes, of two different presentations of micronized vaginal progesterone (400 mg vs. 200 mg) used in endometrial preparation in artificial cycle (AC) for embryo transfer.

This is a non-inferiority, retrospective case-control study, with at least 200 cycles analyzed (at least 100 per arm) and the primary outcome is the serum progesterone level on the day of the embryo transfer.

Condition or Disease	Intervention/Treatment	Phase
Luteal Phase Defect	Drug: Vaginally administered progesterone

Study Design

Study Type:

Observational

Actual Enrollment :

347 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Progesterone Levels and Clinical Outcomes Using a Single Pessary of 400 mg of Vaginal Progesterone in Substitutive Cycles for Embryo Transfer.

Actual Study Start Date :

Mar 3, 2021

Actual Primary Completion Date :

Mar 3, 2021

Actual Study Completion Date :

Mar 17, 2021

Arms and Interventions

Arm	Intervention/Treatment
400 mg Treatments where 400 mg tablet presentation of micronized vaginal progesterone was used, the protocol being one vaginal tablet twice a day.	Drug: Vaginally administered progesterone The artificial endometrial preparation for an embryo transfer with the use of 400 mg vaginal tablet (one tablet twice a day) or 200 mg (two tablets twice a day)
200 mg Treatments where 200 mg tablet presentation of micronized vaginal progesterone was used, the protocol being two vaginal tablets twice a day.	Drug: Vaginally administered progesterone The artificial endometrial preparation for an embryo transfer with the use of 400 mg vaginal tablet (one tablet twice a day) or 200 mg (two tablets twice a day)

Arm

Intervention/Treatment

400 mg

Treatments where 400 mg tablet presentation of micronized vaginal progesterone was used, the protocol being one vaginal tablet twice a day.

Drug: Vaginally administered progesterone

The artificial endometrial preparation for an embryo transfer with the use of 400 mg vaginal tablet (one tablet twice a day) or 200 mg (two tablets twice a day)

200 mg

Treatments where 200 mg tablet presentation of micronized vaginal progesterone was used, the protocol being two vaginal tablets twice a day.

Drug: Vaginally administered progesterone

The artificial endometrial preparation for an embryo transfer with the use of 400 mg vaginal tablet (one tablet twice a day) or 200 mg (two tablets twice a day)

Outcome Measures

Primary Outcome Measures

Serum progesterone level [On the day of embryo transfer]

Secondary Outcome Measures

Need for additional progesterone supplementation [assessed on the day of the embryo transfer]
Clinical results (ongoing pregnancy and miscarriage rate) [assessed on the day of the pregnancy test and during the pregnancy evolution]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients with primary or secondary infertility undergoing endometrial preparation for an embryo transfer using standard doses of oral or transdermal estrogens.
Age between 18 and 50 years.
Normal uterine cavity verified by imaging techniques.
Serum progesterone documented on the day of embryo transfer.

Exclusion Criteria:

Patients with a history of endometritis.
Patients diagnosed with Asherman's syndrome.
Patients with a different supplementation regimen or doses than those of the study groups.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Instituto Bernabeu	Alicante	Comunidad Valenciana	Spain	03016

Sponsors and Collaborators

Instituto Bernabeu

Investigators

Principal Investigator: Joaquín Llácer, MD PhD, Instituto Bernabeu

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joaquín Llácer, Principal Investigator, Instituto Bernabeu

ClinicalTrials.gov Identifier:

NCT04722471

Other Study ID Numbers:

IB-1201

First Posted:

Jan 25, 2021

Last Update Posted:

Mar 19, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Joaquín Llácer, Principal Investigator, Instituto Bernabeu

Frozen embryo transfer

endometrial preparation

artificial cycle

progesterone

Additional relevant MeSH terms:

Progesterone

Study Results

No Results Posted as of Mar 19, 2021