Clinical trial NCT04722471: Progesterone Levels and Clinical Outcomes Using a Single Pessary of 400 mg of Vaginal Progesterone in Substitutive Cycles for Embryo Transfer.
Official title: Progesterone Levels and Clinical Outcomes Using a Single Pessary of 400 mg of Vaginal Progesterone in Substitutive Cycles for Embryo Transfer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Luteal Phase Defect
Keywords: Frozen embryo transfer
endometrial preparation
artificial cycle
progesterone
Lead sponsor: Instituto Bernabeu
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 347
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Serum progesterone level
timeFrame: On the day of embryo transfer
Secondary outcomes:
measure: Need for additional progesterone supplementation
timeFrame: assessed on the day of the embryo transfer
measure: Clinical results (ongoing pregnancy and miscarriage rate)
timeFrame: assessed on the day of the pregnancy test and during the pregnancy evolution
Other outcomes:
Locations:
city: Alicante
country: Spain
facility: Instituto Bernabeu
state: Comunidad Valenciana
Study officials:
affiliation: Instituto Bernabeu
name: Joaquín Llácer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.