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This study evaluates the clinical efficacy of 3 different luteal phase support in patients undergoing frozen-thawed embryo transfer cycles. Endometrium preparation will be hormone replacement in all cycles. Starting from day 11, group 1 will receive 100 mg micronized progesterone parenteral daily injections, group 2 will receive 90 mg bioadhesive gel vaginal twice daily and group 3 will receive 40 mg oral dydrogesterone daily tablets.
In natural pregnancy, successful implantation and pregnancy necessitates well-functioning corpus luteum. Luteal phase support (LPS) is critical in assisted conception cycles particularly for replacement frozen embryo transfer cycles owing to lack of corpus luteum. 3 different LPS options have been suggested:
The investigator's aim is to compare 3 widely used LPS in frozen-thawed embryo transfer cycles.
Following allocation of the subjects, hormone replacement will be scheduled for the endometrial preparation. Briefly; On day 2 of menstrual bleeding, endometrial preparation with oral estradiol (E2) (2 mg twice daily) will be initiated. Approximately 10 days after initiation of E2 administration, the subject will undergo a transvaginal ultrasound examination to assess endometrial development and serum progesterone (P) level will be checked. Once the subject achieved a trilaminar endometrium with a thickness of >7 mm with serum P levels <1.5 ng/ml, she will start the progesterone treatment to which she will be randomized to one of the 3 arms. After 3 days of P treatment along with E2 pills, cleavage embryo transfer will be performed. If the subject will receive blastocyst, 5 days of P treatment will be scheduled.
If these criteria were not met at the first evaluation, she will allowed up to 10 additional days (20 days total) of estrogen stimulation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intramuscular progesterone | Active Comparator | progestan (progesterone) 50 mg/ml ampoules, 2 ampoules (100 mg) intramuscular starting from day 11 of the endometrial preparation cycle. |
|
| vaginal progesterone | Active Comparator | crinone %8 bioadhesive gel (progesterone) 90 mg, twice daily (180 mg/day) starting from day 11 of the endometrial preparation cycle. |
|
| oral dydrogesterone | Experimental | oral dydrogesterone (progesterone) 10 mg tablets, 2x2 (40 mg total) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dydrogesterone 10Mg Tablet (duphaston) | Drug | 40 mg daily oral tablets |
| |
| Measure | Description | Time Frame |
|---|---|---|
| ongoing pregnancy rate | fetal cardiac activity beyond 12th week of gestation | 12th week of pregnancy |
| Measure | Description | Time Frame |
|---|---|---|
| clinical pregnancy rate | fetal cardiac activity | 6th week of pregnancy |
| abortion rate | miscarriage of the pregnancy pregnancy recently confirmed with positive beta hCG blood test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emre Pabuccu, Assoc. Prof. | Ufuk University School of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ufuk University School of Medicine | Ankara | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29338855 | Result | Devine K, Richter KS, Widra EA, McKeeby JL. Vitrified blastocyst transfer cycles with the use of only vaginal progesterone replacement with Endometrin have inferior ongoing pregnancy rates: results from the planned interim analysis of a three-arm randomized controlled noninferiority trial. Fertil Steril. 2018 Feb;109(2):266-275. doi: 10.1016/j.fertnstert.2017.11.004. Epub 2018 Jan 17. | |
| 30304457 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 4, 2022 | |
| Reset | Sep 30, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 4, 2022 | Sep 30, 2022 |
| ID | Term |
|---|---|
| D004394 | Dydrogesterone |
| D013607 | Tablets |
| D011374 | Progesterone |
| D009821 | Oils |
| C400424 | Crinone |
| D014622 | Vaginal Creams, Foams, and Jellies |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Progesterone 50Mg/mL Oil |
| Drug |
100 mg daily intramuscular injections |
|
| Crinone 8% Vaginal Gel | Drug | 180 mg daily vaginal gels |
|
| during first 10 weeks of gestation |
| Result |
| Griesinger G, Blockeel C, Sukhikh GT, Patki A, Dhorepatil B, Yang DZ, Chen ZJ, Kahler E, Pexman-Fieth C, Tournaye H. Oral dydrogesterone versus intravaginal micronized progesterone gel for luteal phase support in IVF: a randomized clinical trial. Hum Reprod. 2018 Dec 1;33(12):2212-2221. doi: 10.1093/humrep/dey306. |
| 27761732 | Result | Zarei A, Sohail P, Parsanezhad ME, Alborzi S, Samsami A, Azizi M. Comparison of four protocols for luteal phase support in frozen-thawed Embryo transfer cycles: a randomized clinical trial. Arch Gynecol Obstet. 2017 Jan;295(1):239-246. doi: 10.1007/s00404-016-4217-4. Epub 2016 Oct 19. |
| D011083 |
| Polycyclic Compounds |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D008055 | Lipids |
| D053566 | Feminine Hygiene Products |
| D004864 | Equipment and Supplies |