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Serum progesterone levels will be evaluated at four different time points during the day of an artificially prepared frozen embryo transfer cycle (HRT FET cycle) and a modified natural cycle frozen embryo transfer cycle (mNC FET cycle) (at 08:00, 12:00, 16:00 and 20:00).The pairwise percentage differences in serum progesterone levels for each patient will be calculated. The intra-day variability of progesterone will be analyzed using mixed models. Pregnancy outcomes will also be assessed. The sample size calculated consisted of 22 patients for the HRT-FET study and 22 patients for the mNC FET study.
In the HRT FET, estradiol valerate (Progynova) will be administered for endometrial preparation. If the endometrial thickness will be ≥ 6,5 mm during an ultrasound scan planned following an initial period of estrogen priming, micronized vaginal progesterone will be started (Utrogestan 800 mg/d). The transfer of a single blastocyst will be performed on the 6th day of progesterone administration. In a modified NC FET, there is no intake of medication but endocrine and ultrasound monitoring during the proliferative phase. Ovulation trigger with hCG will be considered when a dominant follicle between 16 and 20 mm will be observed and when the endometrial thickness will be ≥ 6,5 mm. The transfer of a single blastocyst will take place on the 7th day after hCG injection.
Serum progesterone levels will be evaluated at four different time points during the day of an artificially prepared frozen embryo transfer cycle (HRT FET cycle) and a modified natural cycle frozen embryo transfer cycle (mNC FET cycle) (at 08:00, 12:00, 16:00 and 20:00). Pairwise percentage differences in serum progesterone levels for each patient will be calculated. The intra-day variability of progesterone will be analyzed using mixed models. Pregnancy outcomes will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Frozen embryo transfer cycle | Experimental | Patients who will undergo a frozen embryo transfer in the modified natural cycle and in an artificially prepared cycle will be included |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood test | Biological | four blood samples will be withdrawn from the participants during the day of their frozen embryo transfer cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| The existence of circadian variability of serum progesterone during the day of a frozen embryo transfer | To evaluate if there is significant variability in circadian level of serum progesterone on the day of an artificially prepared frozen embryo transfer cycle and during the day of a modified natural frozen embryo transfer cycle | the day of the embryo transfer (from 8 am to 8 pm) |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy outcomes after the frozen embryo transfer | To evaluate the Clinical pregnancy rate (CPR) in patients who underwent HRT FET or mNC FET. CPR is defined as a pregnancy documented by ultrasound at 6-8 gestational weeks that showed a gestational sac in the uterus | from the day of the embryo transfer to 12 weeks of pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christophe Blockeel, MD | Universitair Ziekenhuis Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brussels IVF | Brussels | Jette | 1090 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29025055 | Background | Mackens S, Santos-Ribeiro S, van de Vijver A, Racca A, Van Landuyt L, Tournaye H, Blockeel C. Frozen embryo transfer: a review on the optimal endometrial preparation and timing. Hum Reprod. 2017 Nov 1;32(11):2234-2242. doi: 10.1093/humrep/dex285. | |
| 34384594 | Background | Melo P, Chung Y, Pickering O, Price MJ, Fishel S, Khairy M, Kingsland C, Lowe P, Petsas G, Rajkhowa M, Sephton V, Tozer A, Wood S, Labarta E, Wilcox M, Devall A, Gallos I, Coomarasamy A. Serum luteal phase progesterone in women undergoing frozen embryo transfer in assisted conception: a systematic review and meta-analysis. Fertil Steril. 2021 Dec;116(6):1534-1556. doi: 10.1016/j.fertnstert.2021.07.002. Epub 2021 Aug 10. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 8, 2024 | |
| Reset | Oct 30, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 8, 2024 | Oct 30, 2024 |
| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| The critical progesterone threshold to optimize pregnancy outcomes |
To evaluate the critical threshold of serum progesterone on the day of the FET below which pregnancy rates are significantly lower |
| from the day of the embryo transfer to 12 weeks of pregnancy |
| The assessment of serum progesterone on the day of frozen embryo transfer | To study when is the best moment to measure serum progesterone on the day of FET | the day of the embryo transfer (from 8 am to 8 pm) |
| Pregnancy outcomes after the frozen embryo transfer | To evaluate the on going pregnancy rate (OPR) in patients who underwent HRT FET or mNC FET. OPR is defined as a viable pregnancy at the ultrasound taken at 12 weeks of gestation that shows the presence of fetal heartbeat | from the day of the embryo transfer to 7 weeks of pregnancy |
| 34548167 | Background | Labarta E, Mariani G, Rodriguez-Varela C, Bosch E. Individualized luteal phase support normalizes live birth rate in women with low progesterone levels on the day of embryo transfer in artificial endometrial preparation cycles. Fertil Steril. 2022 Jan;117(1):96-103. doi: 10.1016/j.fertnstert.2021.08.040. Epub 2021 Sep 20. |
| 32322584 | Background | Wang Z, Liu H, Song H, Li X, Jiang J, Sheng Y, Shi Y. Increased Risk of Pre-eclampsia After Frozen-Thawed Embryo Transfer in Programming Cycles. Front Med (Lausanne). 2020 Apr 8;7:104. doi: 10.3389/fmed.2020.00104. eCollection 2020. |
| 34177806 | Background | Labarta E, Rodriguez-Varela C, Mariani G, Bosch E. Serum Progesterone Profile Across the Mid and Late Luteal Phase in Artificial Cycles Is Associated With Pregnancy Outcome. Front Endocrinol (Lausanne). 2021 Jun 10;12:665717. doi: 10.3389/fendo.2021.665717. eCollection 2021. |
| 38775072 | Derived | Loreti S, Roelens C, Aktoz F, Niero M, De Munck N, Tournaye H, Mackens S, Blockeel C. Circadian serum progesterone variations on the day of frozen embryo transfer in a modified natural cycle protocol. Hum Reprod. 2024 May 22:deae101. doi: 10.1093/humrep/deae101. Online ahead of print. |