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

NCT04722471 | Completed

• 1 other identifier: IB-1201
• Study Type: observational
• Target: 347
• Locations: 1 country
• Sites: 1

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.

Conditions

Luteal Phase Defect

Keywords

Frozen embryo transfer; endometrial preparation; artificial cycle; progesterone

Outcome Measures

Primary Outcomes (1)

• Serum progesterone level

  On the day of embryo transfer

Secondary Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

Vaginally administered progesterone DRUG

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; 400 mg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The population will be selected among those patients who have undergone embryo transfer treatment with endometrial preparation in a artificial cycle at the Instituto Bernabeu.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto Bernabeu: lead

Study Sites (1)

Instituto Bernabeu

Alicante, Valencia, 03016, Spain

Location

Related Publications (2)

• Labarta E, Mariani G, Holtmann N, Celada P, Remohi 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 study. Hum Reprod. 2017 Dec 1;32(12):2437-2442. doi: 10.1093/humrep/dex316.

  PMID: 29040638 RESULT

• Labarta E, Mariani G, Paolelli S, Rodriguez-Varela C, Vidal C, Giles J, Bellver J, Cruz F, Marzal A, Celada P, Olmo I, Alama P, Remohi J, Bosch E. Impact of low serum progesterone levels on the day of embryo transfer on pregnancy outcome: a prospective cohort study in artificial cycles with vaginal progesterone. Hum Reprod. 2021 Feb 18;36(3):683-692. doi: 10.1093/humrep/deaa322.

  PMID: 33340402 RESULT

Study Officials

• Joaquín Llácer, MD PhD

  Instituto Bernabeu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 25, 2021
• Study Start: March 3, 2021
• Primary Completion: March 3, 2021
• Study Completion: March 17, 2021
• Last Updated: March 19, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)