Progesterone Levels and Endometrial Compaction in Frozen-Thawed Embryo Transfer Cycles

Infertility, Female Clinical Trial

Official title:

The Correlation of Serum Progesterone Levels With the Degree of Endometrial Compaction on the Day of Frozen Embryo Transfer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04554654
• Other study ID #: 9995381
• Status: Recruiting
• Start date: June 15, 2020
• Est. completion date: February 15, 2021

Study information

• Verified date: January 2021
• Source: Memorial Atasehir Hospital
• Contact: Cem Demirel, MD
• Phone: +905333229039
• Email: cemdemirel[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Implantation; Placenta
• Infertility
• Infertility of Uterine Origin
• Infertility, Female

Intervention

Diagnostic Test:
• transvaginal ultrasound,
transvaginal ultrasound performed on day of the start of progesterone supplementation and on the day of frozen embryo transfer; serum progesterone level measurement on day of frozen embryo transfer

Locations

Country	Name	City	State
Turkey	Atasehir Memorial Hospital IVF Department	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Cem Demirel

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rates	Presence of at least one live fetus at the end of the 12th gestational week in patients with endometrial compaction compared to patients without endometrial compaction after frozen embryo transfer	12 weeks after the last menstrual period of the patient
Secondary	The Correlation of Serum Progesterone Levels With the Degree of Endometrial Compaction on the Day of Frozen Embryo Transfer	endometrium compacted (became thinner) after the administration of progesterone	On the day of frozen embryo transfer
Secondary	Clinical pregnancy rate	Presence of an intrauterine gestational sac with fetal heart beat at 7th week of gestation	6-7 weeks after the last menstrual period of the patient
Secondary	Implantation rate	Percentage of gestational sacs compared to the number of embryos transferred	5 weeks after the last menstrual period of the patient
Secondary	Clinical miscarriage rate	pregnancy loss after ultrasonographic detection of an intrauterine gestational sac	after 5th gestational week