Implantation; Placenta, Infertility, Female, Infertility of Uterine Origin
Conditions
Keywords
frozen-thawed embryo transfer, endometrial compaction, progesterone
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.
Interventions
DIAGNOSTIC_TESTtransvaginal 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
Sponsors
Cem Demirel
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy rates | 12 weeks after the last menstrual period of the patient | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Correlation of Serum Progesterone Levels With the Degree of Endometrial Compaction on the Day of Frozen Embryo Transfer | On the day of frozen embryo transfer | endometrium compacted (became thinner) after the administration of progesterone |
| Clinical pregnancy rate | 6-7 weeks after the last menstrual period of the patient | Presence of an intrauterine gestational sac with fetal heart beat at 7th week of gestation |
| Implantation rate | 5 weeks after the last menstrual period of the patient | Percentage of gestational sacs compared to the number of embryos transferred |
| Clinical miscarriage rate | after 5th gestational week | pregnancy loss after ultrasonographic detection of an intrauterine gestational sac |
Countries
Turkey (Türkiye)
Contacts
Primary ContactCem Demirel, MD
Outcome results
None listed