Clinical trial NCT04733235: the Effect of Endometrial Compaction Caused by Progesterone Effect on Pregnancy Outcomes
Official title: The Effect of Progesterone Induced Endometrial Compaction on Pregnancy Outcomes in Frozen-thawed Embryo Transfer at the Blastocyst Stage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Female Infertility
Frozen-thawed Embryo Transfer
Keywords: infertility
female infertility
frozen- thawed embryo transfer
female
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2021-02-02
Enrollment: 205
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women underwent frozen embryo transfer

Brief summary: The purpose of this prospective cohort study is to assess the effect of endometrial compaction caused by progesterone effect on pregnancy outcomes

Detailed description: For a pregnancy to occur, the embryo must implant in a receptive endometrium during the window of implantation, which is thought to occur from day 22 to 24 of an idealized 28-day cycle. Early studies have suggested that assessing endometrial thickness with the use of ultrasound may be an alternative to invasive techniques such as endometrial biopsy for attempting to determine a receptive endometrium for frozen-thawed embryo transfer (FET).

A preovulatory endometrial thickness of 7 mm or more is considered to be the cutoff for endometrial receptivity, below which many physicians would cancel an embryo transfer. However, in most studies in the literature, endometrial thickness was measured either on the day of hCG in fresh embryo transfer cases or on the last day of estrogen treatment in thawed embryo transfers. There are a limited number of studies evaluating the luteal period, embryo transfer day and endometrial thickness.

Accordingly, in this prospective cohort study is to assess the effect of endometrial compaction caused by progesterone effect on pregnancy outcomes

Eligibility criteria: Inclusion Criteria:

1. Woman aged 18-40 years
2. Presence of high quality (\>2BB) blastocyst
3. Hormonal(estrogen and progesterone) frozen- thawed embryo transfer cycles
4. presence of high quality blastocyst cryopreserved by vitrification method.
5. A single embryo transfer

Exclusion Criteria:

1. Presence of uterine pathology
2. Participants whose optimal endometrial image cannot be obtained due to uterine position
3. Participants whose treatments were canceled for any reason before embryo transfer
4. Participants which had embryo transfer on the day 2 or 3 (at the cleavage stage)
5. Participants who had 2 embryo transfer
6. Presence of low quality (\<2BB) blastocyst
7. \> 15% loss of viability in the embryo during embryo thawing

Primary outcomes:
measure: The change in endometrial thickness
timeFrame: 1 year
measure: ongoing pregnancy rates.
timeFrame: 1 year
Secondary outcomes:
measure: The Correlation of Serum Progesterone Levels With the Degree of Endometrial Compaction on the Day of Frozen Embryo Transfer
timeFrame: On the day of frozen embryo transfer
measure: Clinical pregnancy rate
timeFrame: 6-7 weeks after the last menstrual period of the patient
measure: Implantation rate
timeFrame: 5 weeks after the last menstrual period of the patient
measure: Clinical miscarriage
timeFrame: after 5th gestational week
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
References:
citation: Haas J, Smith R, Zilberberg E, Nayot D, Meriano J, Barzilay E, Casper RF. Endometrial compaction (decreased thickness) in response to progesterone results in optimal pregnancy outcome in frozen-thawed embryo transfers. Fertil Steril. 2019 Sep;112(3):503-509.e1. doi: 10.1016/j.fertnstert.2019.05.001. Epub 2019 Jun 24.