Clinical trial NCT04554654: Progesterone Levels and Endometrial Compaction in Frozen-Thawed Embryo Transfer Cycles
Official title: The Correlation of Serum Progesterone Levels With the Degree of Endometrial Compaction on the Day of Frozen Embryo Transfer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility, Female
Infertility of Uterine Origin
Implantation; Placenta
Keywords: frozen-thawed embryo transfer
endometrial compaction
progesterone
Lead sponsor: Memorial Ataşehir Hospital
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women underwent frozen embryo transfer

Brief summary: This study is intended to determine whether there is a correlation between endometrial compaction and serum progesterone levels on the day of frozen embryo transfers by using transvaginal sonography for the endometrial assessment.

Detailed description: This study is planned to be conducted by prospectively evaluating approximately 200 frozen embryo transfers within 6 months in a single center. Patients planned to be included in the study are started estrodiol 6 mg / day on day2-3 of mensturation. 12 days after the start of estrogen, patients who have endometrial thickness over 7 mm are then started vaginal progesterone supplementation as per routine practice and are eventually proceeded to embryo transfer either on day 4 or 6 of progesterone supplementation. In this study investigators are intended to measure endometrial thickness transvaginally on the day of embryo transfer to accurately determine the presence of endometrial compaction, assess serum progesterone levels, evaluate any possible correlations between endometrial compaction, serum progesterone levels and pregnancy rates.

Eligibility criteria: Inclusion Criteria:

1. Woman aged 20-40 years
2. Hormonal(estrogen and progesterone) frozen- thawed embryo transfer cycles
3. Having available blastocyst(s) cryopreserved by vitrification method.

Exclusion Criteria:

1. Recurrent implantation failure
2. Recurrent pregnancy loss
3. Presence of uterine pathology
4. Requirement for fresh embryo(s);
5. Presence of any clinically relevant systemic disease contraindicated for assisted reproduction or pregnancy
6. Allergy history for relevant drugs
7. Body mass index of \<18 or \>38 kg/m2 at screening
8. Current breastfeeding or pregnancy
9. Refusal or inability to comply with the requirements of the protocol for any reason, including scheduled clinic visits and laboratory tests
10. Natural or modified natural cycles

Primary outcomes:
measure: Ongoing pregnancy rates
timeFrame: 12 weeks after the last menstrual period of the patient
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 rate
timeFrame: after 5th gestational week
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Ataşehir Memorial Hospital IVF Department
Study officials:
References: