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

Luteal Phase Defect Clinical Trial

— CycloCT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04722471
• Other study ID #: IB-1201
• Status: Completed
• Start date: March 3, 2021
• Est. completion date: March 17, 2021

Study information

• Verified date: March 2021
• Source: Instituto Bernabeu
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: March 17, 2021
• Est. primary completion date: March 3, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Luteal Phase Defect

Intervention

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)

Locations

Country	Name	City	State
Spain	Instituto Bernabeu	Alicante	Comunidad Valenciana

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Bernabeu

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Labarta E, Mariani G, Holtmann N, Celada P, Remohí J, Bosch E. Low serum progesterone on the day of embryo transfer is associated with a diminished ongoing pregnancy rate in oocyte donation cycles after artificial endometrial preparation: a prospective st — View Citation

Labarta E, Mariani G, Paolelli S, Rodriguez-Varela C, Vidal C, Giles J, Bellver J, Cruz F, Marzal A, Celada P, Olmo I, Alamá P, Remohi J, Bosch E. Impact of low serum progesterone levels on the day of embryo transfer on pregnancy outcome: a prospective co — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum progesterone level		On the day of embryo transfer
Secondary	Need for additional progesterone supplementation		assessed on the day of the embryo transfer
Secondary	Clinical results (ongoing pregnancy and miscarriage rate)		assessed on the day of the pregnancy test and during the pregnancy evolution