- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05473273
Descriptive Analysis of Serum Immunological Markers During an Euploid Frozen Embryo Transfer in a Natural Cycle.
Descriptive Analysis of Serum Immunological Markers During an Euploid Frozen Embryo Transfer in a Natural Cycle (NC).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: SUZAN SAMIR
- Phone Number: 97126528000
- Email: suzan.samir@artfertilityclinics.com
Study Contact Backup
- Name: BARBARA LAWRENZ, PhD
- Phone Number: 1108 97126528000
- Email: barbara.lawrenz@artfertilityclinics.com
Study Locations
-
-
-
Abu Dhabi, United Arab Emirates, 60202
- Recruiting
- ART Fertility Clinics LLC
-
Contact:
- Barbara Lawrenz, PhD
- Phone Number: +97102 652 8000
- Email: suzan.samir@artfertilityclinics.com
-
Principal Investigator:
- Laura Marqueta Marques
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Women aged 18 years to 40 years
- Having at least one good quality (grade A or B for inner mass cell and trophectoderm) day 5 or 6 chromosomally normal cryopreserved blastocyst available for transfer
- Single embryo transfer in a natural cycle (NC) or an Hormone Replacement Therapy (HRT) protocol
- Fresh ejaculate used for fertilization
Exclusion Criteria:
- Body mass index lower than 18.5 or equal or higher than 29 kg/m2
- Endometriosis or adenomyosis suspected by medical history (dysmenorrhea, dyspareunia, heavy or prolonged menstrual bleeding (> 8 days), chronic pelvic pain, catamenial rectal or bladder symptoms) or diagnosed by imaging (magnetic resonance imaging or ultrasonography)
- Uterine abnormalities
- Hydrosalpinx
- Insulin resistance or diabetes mellitus diagnosed by HbA1c 5.7 %
- Antiphospholipid syndrome
- Polycystic ovarian syndrome according to Rotterdam criteria: presence of at least two of the following: irregular cycles (< 21 or > 35 days or < 8 cycles a year), biochemical or clinical hyperandrogenism, ovarian ultrasound morphology (> 20 follicles per ovary on transvaginal scan) or Anti-mullerian hormone > 5,98 ng/ml
- History of recurrent miscarriage, defined as the loss of 2 or more pregnancies according to ESHRE guidelines
- History of implantation failure, considered as the lack of pregnancy after the transfer of 2 good-quality (grade A or B for inner mass cell and trophectoderm (29)) euploid embryos
- History or suspicion of Asherman syndrome
- Autoimmune disease
- Couple first degree consanguineous
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Natural Cycle Protocol
Ultrasound monitoring to monitor follicular and endometrial growth. Serial measurements of serum Lutenizing Hormone (LH), estradiol (E2), and progesterone (P4) to identify ovulation. Minimal endometrial thickness of 7 mm is required. No progesterone supplementation. Embryo transfer (ET) will be scheduled 5 days after the day of ovulation (120 hours of P4 exposure). Blood samples will be drawn to measure PIBF, IL-17, IFγ, IL-10, IL-4 and TGF-ß1 on day of ovulation (P4 rise), on the day before ET, on the day of ET and 3 and 10 days later, between 9 and 12 am. A blood test to measure beta human chorionic gonadotropin (ß-hCG) will be performed 3 and 10 days after ET and at 5 weeks +/- 3 days in case of pregnancy, between 9 and 12 am. In case of pregnancy, a blood test to measure PIBF, IL-17, IFγ, IL-10, IL-4 and TGF-ß1 will be performed at 5 weeks +/- 3 days between 9 and 12 am.. |
|
Hormone Replacement Therapy Protocol
Ultrasound monitoring of endometrial growth and exclude growing follicle Oral Estradiol Valerate (Progyluton) 4 mg on cycle day 2 at 7 pm for 2 days. On 3rd day, increase dose to 6 mg. The dose may be increased based on endometrial thickness. Once endometrial thickness is at least 7 mm and trilaminar, after 10-15 days of Estradiol Valerate administration, start Endometrin 100 mg at 1 pm and 9 pm. From 2nd day onwards increase to 3 times daily. Continue Progyluton & Endometrin until 12 weeks of pregnancy ET on the 5th full day of Endometrin administration Blood test to measure PIBF, IL-17, IFγ, IL-4, IL-10 and TGF-ß1 on the 1st day of Endometrin supplementation (before 1st administration), on the 4th day of Endometrin administration, on the day of ET and 3 and10 days after, 4 to 7 hours after the morning administration. Blood test to measure beta human chorionic gonadotropin (ß-hCG) will be performed 3 and 10 days after ET and at 5 weeks +/- 3 days if pregnancy. |
Endometrin will start once endometrial thickness is equal or higher to 7 mm with a trilaminar appearance, after at least 10 days and always less than 16 days of estradiol administration.
First day of supplementation a dose of 100mg will be administered at of at 1.pm and 9 pm.
From the second day and onwards administration will be increased to three times daily, at 6 am, 2 pm and 10 pm
Estradiol valerate dose will be reduced to 4mg daily at 7 pm during the first two days of vaginal natural micronized progesterone supplementation and increased afterwards to 6 mg daily (2 mg at 10 am and 4 mg at 7 pm).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood levels of IL-4 (Interleukin 4) on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
Time Frame: 1 day
|
Blood levels of IL-4 on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
|
1 day
|
Blood levels of IL-10 (Interleukin 10) on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
Time Frame: 1 day
|
Blood levels of IL-10 on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
|
1 day
|
Blood levels of IL-17 (Interleukin 17) on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
Time Frame: 1 day
|
Blood levels of IL-17 on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
|
1 day
|
Blood levels of TGF-ß1 (Transforming Growth Factor beta1) on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
Time Frame: 1 day
|
Blood levels of TGF-ß1 on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
|
1 day
|
Blood levels of IFγ (Interferon gamma) on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
Time Frame: 1 day
|
Blood levels of IFγ on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
|
1 day
|
Blood levels of PIBF on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
Time Frame: 1 day
|
Blood levels of PIBF on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
|
1 day
|
Blood levels of IL-4 (Interleukin 4) on the day before embryo transfer
Time Frame: 1 day
|
Blood levels of IL-4 on the day before embryo transfer
|
1 day
|
Blood levels of IL-10 (Interleukin 10) on the day before embryo transfer
Time Frame: 1 day
|
Blood levels of IL-10 on the day before embryo transfer
|
1 day
|
Blood levels of IL-17 (Interleukin 17) on the day before embryo transfer
Time Frame: 1 day
|
Blood levels of IL-17 on the day before embryo transfer
|
1 day
|
Blood levels of TGF-ß1 (Transforming Growth Factor beta1) on the day before embryo transfer
Time Frame: 1 day
|
Blood levels of TGF-ß1 on the day before embryo transfer
|
1 day
|
Blood levels of IFγ (Interferon gamma) on the day before embryo transfer
Time Frame: 1 day
|
Blood levels of IFγ on the day before embryo transfer
|
1 day
|
Blood levels of PIBF (Progesterone induced blocking factor) on the day before embryo transfer
Time Frame: 1 day
|
Blood levels of PIBF on the day before embryo transfer
|
1 day
|
Blood levels of IL-4 (Interleukin 4) on the day of embryo transfer
Time Frame: 1 day
|
Blood levels of IL-4 on the day of embryo transfer
|
1 day
|
Blood levels of IL-10 (Interleukin 10) on the day of embryo transfer
Time Frame: 1 day
|
Blood levels of IL-10 on the day of embryo transfer
|
1 day
|
Blood levels of IL-17 (Interleukin 17) on the day of embryo transfer
Time Frame: 1 day
|
Blood levels of IL-17 on the day of embryo transfer
|
1 day
|
Blood levels of TGF-ß1 (Transforming Growth Factor beta1) on the day of embryo transfer
Time Frame: 1 day
|
Blood levels of TGF-ß1 on the day of embryo transfer
|
1 day
|
Blood levels of IFγ (Interferon gamma) on the day of embryo transfer
Time Frame: 1 day
|
Blood levels of IFγ on the day of embryo transfer
|
1 day
|
Blood levels of PIBF (Progesterone induced blocking factor) on the day of embryo transfer
Time Frame: 1 day
|
Blood levels of PIBF on the day of embryo transfer
|
1 day
|
Blood levels of IL-4 (Interleukin 4) three days after embryo transfer
Time Frame: 3 days
|
Blood levels of IL-4 three days after embryo transfer
|
3 days
|
Blood levels of IL-10 (Interleukin 10) three days after embryo transfer
Time Frame: 3 days
|
Blood levels of IL-10 three days after embryo transfer
|
3 days
|
Blood levels of IL-17 (Interleukin 17) three days after embryo transfer
Time Frame: 3 days
|
Blood levels of IL-17 three days after embryo transfer
|
3 days
|
Blood levels of TGF-ß1 (Transforming Growth Factor beta1) three days after embryo transfer
Time Frame: 3 days
|
Blood levels of TGF-ß1 three days after embryo transfer
|
3 days
|
Blood levels of IFγ (Interferon gamma) three days after embryo transfer
Time Frame: 3 days
|
Blood levels of IFγ three days after embryo transfer
|
3 days
|
Blood levels of PIBF (Progesterone induced blocking factor) three days after embryo transfer
Time Frame: 3 days
|
Blood levels of PIBF three days after embryo transfer
|
3 days
|
Blood levels of IL-4 (Interleukin 4) ten days after embryo transfer
Time Frame: 10 days
|
Blood levels of IL-4 ten days after embryo transfer
|
10 days
|
Blood levels of IL-10 (Interleukin 10) ten days after embryo transfer
Time Frame: 10 days
|
Blood levels of IL-10 ten days after embryo transfer
|
10 days
|
Blood levels of IL-17 (Interleukin 17) ten days after embryo transfer
Time Frame: 10 days
|
Blood levels of IL-17 ten days after embryo transfer
|
10 days
|
Blood levels of TGF-ß1 (Transforming Growth Factor beta1) ten days after embryo transfer
Time Frame: 10 days
|
Blood levels of TGF-ß1 ten days after embryo transfer
|
10 days
|
Blood levels of IFγ (Interferon gamma) ten days after embryo transfer
Time Frame: 10 days
|
Blood levels of IFγ ten days after embryo transfer
|
10 days
|
Blood levels of PIBF (Progesterone induced blocking factor) ten days after embryo transfer
Time Frame: 10 days
|
Blood levels of PIBF ten days after embryo transfer
|
10 days
|
Blood levels of IL-4 (Interleukin 4) in case of pregnancy at 5 weeks +/- 3 days
Time Frame: 5 weeks
|
Blood levels of IL-4 in case of pregnancy at 5 weeks +/- 3 days
|
5 weeks
|
Blood levels of IL-10 (Interleukin 10) in case of pregnancy at 5 weeks +/- 3 days
Time Frame: 5 weeks
|
Blood levels of IL-10 in case of pregnancy at 5 weeks +/- 3 days
|
5 weeks
|
Blood levels of IL-17 (Interleukin 17) in case of pregnancy at 5 weeks +/- 3 days
Time Frame: 5 weeks
|
Blood levels of IL-17 in case of pregnancy at 5 weeks +/- 3 days
|
5 weeks
|
Blood levels of TGF-ß1 (Transforming Growth Factor beta1) in case of pregnancy at 5 weeks +/- 3 days
Time Frame: 5 weeks
|
Blood levels of TGF-ß1 in case of pregnancy at 5 weeks +/- 3 days
|
5 weeks
|
Blood levels of IFγ (Interferon gamma) in case of pregnancy at 5 weeks +/- 3 days
Time Frame: 5 weeks
|
Blood levels of IFγ in case of pregnancy at 5 weeks +/- 3 days
|
5 weeks
|
Blood levels of PIBF (Progesterone induced blocking factor) in case of pregnancy at 5 weeks +/- 3 days
Time Frame: 5 weeks
|
Blood levels of PIBF in case of pregnancy at 5 weeks +/- 3 days
|
5 weeks
|
Blood levels of estradiol on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
Time Frame: 1 day
|
Blood levels of estradiol on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
|
1 day
|
Blood levels of progesterone on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
Time Frame: 1 day
|
Blood levels of progesterone on the on the day of progesterone rise (NC) or first day of progesterone administration (HRT)
|
1 day
|
Blood levels of estradiol on the day before embryo transfer
Time Frame: 1 day
|
Blood levels of estradiol on the day before embryo transfer
|
1 day
|
Blood levels of progesterone on the day before embryo transfer
Time Frame: 1 day
|
Blood levels of progesterone on the day before embryo transfer
|
1 day
|
Blood levels of estradiol on the day of embryo transfer
Time Frame: 1 day
|
Blood levels of estradiol on the day of embryo transfer
|
1 day
|
Blood levels of progesterone on the day of embryo transfer
Time Frame: 1 day
|
Blood levels of progesterone on the day of embryo transfer
|
1 day
|
Blood levels of estradiol three days after embryo transfer
Time Frame: 3 days
|
Blood levels of estradiol three days after embryo transfer
|
3 days
|
Blood levels of progesterone three days after embryo transfer
Time Frame: 3 days
|
Blood levels of progesterone three days after embryo transfer
|
3 days
|
Blood levels of estradiol ten days after embryo transfer
Time Frame: 10 days
|
Blood levels of estradiol ten days after embryo transfer
|
10 days
|
Blood levels of progesterone ten days after embryo transfer
Time Frame: 10 days
|
Blood levels of progesterone ten days after embryo transfer
|
10 days
|
Blood levels of estradiol in case of pregnancy at 5 weeks +/- 3 days
Time Frame: 5 weeks
|
Blood levels of estradiol in case of pregnancy at 5 weeks +/- 3 days
|
5 weeks
|
Blood levels of progesterone in case of pregnancy at 5 weeks +/- 3 days
Time Frame: 5 weeks
|
Blood levels of progesterone in case of pregnancy at 5 weeks +/- 3 days
|
5 weeks
|
Blood levels of ß-hCG (Beta-Human Chorionic Gonadotropin) three days after embryo transfer
Time Frame: 3 days
|
Blood levels of ß-hCG three days after embryo transfer
|
3 days
|
Blood levels of ß-hCG (Beta-Human Chorionic Gonadotropin) ten days after embryo transfer
Time Frame: 10 days
|
Blood levels of ß-hCG ten days after embryo transfer
|
10 days
|
Blood levels of ß-hCG (Beta-Human Chorionic Gonadotropin) in case of pregnancy at 5 weeks +/- 3 days
Time Frame: 5 weeks
|
Blood levels of ß-hCG in case of pregnancy at 5 weeks +/- 3 days
|
5 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pregnancy rate
Time Frame: 10 days
|
Number of patients with a ß-hCG > 5 IU out of the number of patients who underwent an embryo transfer.
|
10 days
|
Clinical pregnancy rate
Time Frame: 5 weeks and 3 days
|
Number of patients with an ultrasonographic visible sac out of the number of patients who underwent an embryo transfer
|
5 weeks and 3 days
|
Miscarriage rate
Time Frame: 12 weeks
|
Number of patients with a pregnancy loss out of the number of patients who had a ß-hCG > 5 IU after embryo transfer
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: LAURA MARQUETA MARQUES, Consultant, ART Fertility Clinics LLC
Publications and helpful links
General Publications
- Rotterdam ESHRE/ASRM-Sponsored PCOS Consensus Workshop Group. Revised 2003 consensus on diagnostic criteria and long-term health risks related to polycystic ovary syndrome. Fertil Steril. 2004 Jan;81(1):19-25. doi: 10.1016/j.fertnstert.2003.10.004.
- Fatemi HM, Kyrou D, Bourgain C, Van den Abbeel E, Griesinger G, Devroey P. Cryopreserved-thawed human embryo transfer: spontaneous natural cycle is superior to human chorionic gonadotropin-induced natural cycle. Fertil Steril. 2010 Nov;94(6):2054-8. doi: 10.1016/j.fertnstert.2009.11.036. Epub 2010 Jan 25.
- Calzada M, Lopez N, Noguera JA, Mendiola J, Hernandez AI, Corbalan S, Sanchez M, Torres AM. AMH in combination with SHBG for the diagnosis of polycystic ovary syndrome. J Obstet Gynaecol. 2019 Nov;39(8):1130-1136. doi: 10.1080/01443615.2019.1587604. Epub 2019 Jun 17.
- Zhang X, Wei H. Role of Decidual Natural Killer Cells in Human Pregnancy and Related Pregnancy Complications. Front Immunol. 2021 Aug 26;12:728291. doi: 10.3389/fimmu.2021.728291. eCollection 2021.
- DeJong CS, Maurice NJ, McCartney SA, Prlic M. Human Tissue-Resident Memory T Cells in the Maternal-Fetal Interface. Lost Soldiers or Special Forces? Cells. 2020 Dec 16;9(12):2699. doi: 10.3390/cells9122699.
- Diaz-Hernandez I, Alecsandru D, Garcia-Velasco JA, Dominguez F. Uterine natural killer cells: from foe to friend in reproduction. Hum Reprod Update. 2021 Jun 22;27(4):720-746. doi: 10.1093/humupd/dmaa062.
- Lucas ES, Vrljicak P, Muter J, Diniz-da-Costa MM, Brighton PJ, Kong CS, Lipecki J, Fishwick KJ, Odendaal J, Ewington LJ, Quenby S, Ott S, Brosens JJ. Recurrent pregnancy loss is associated with a pro-senescent decidual response during the peri-implantation window. Commun Biol. 2020 Jan 21;3(1):37. doi: 10.1038/s42003-020-0763-1.
- Lash GE, Robson SC, Bulmer JN. Review: Functional role of uterine natural killer (uNK) cells in human early pregnancy decidua. Placenta. 2010 Mar;31 Suppl:S87-92. doi: 10.1016/j.placenta.2009.12.022. Epub 2010 Jan 12.
- Liu Y, Gao S, Zhao Y, Wang H, Pan Q, Shao Q. Decidual Natural Killer Cells: A Good Nanny at the Maternal-Fetal Interface During Early Pregnancy. Front Immunol. 2021 May 12;12:663660. doi: 10.3389/fimmu.2021.663660. eCollection 2021.
- Robertson SA, Moldenhauer LM. Immunological determinants of implantation success. Int J Dev Biol. 2014;58(2-4):205-17. doi: 10.1387/ijdb.140096sr.
- Mor G, Aldo P, Alvero AB. The unique immunological and microbial aspects of pregnancy. Nat Rev Immunol. 2017 Aug;17(8):469-482. doi: 10.1038/nri.2017.64. Epub 2017 Jun 19.
- Piccinni MP, Raghupathy R, Saito S, Szekeres-Bartho J. Cytokines, Hormones and Cellular Regulatory Mechanisms Favoring Successful Reproduction. Front Immunol. 2021 Jul 28;12:717808. doi: 10.3389/fimmu.2021.717808. eCollection 2021.
- AbdulHussain G, Azizieh F, Makhseed M, Raghupathy R. Effects of Progesterone, Dydrogesterone and Estrogen on the Production of Th1/Th2/Th17 Cytokines by Lymphocytes from Women with Recurrent Spontaneous Miscarriage. J Reprod Immunol. 2020 Aug;140:103132. doi: 10.1016/j.jri.2020.103132. Epub 2020 Apr 17.
- Salem ML. Estrogen, a double-edged sword: modulation of TH1- and TH2-mediated inflammations by differential regulation of TH1/TH2 cytokine production. Curr Drug Targets Inflamm Allergy. 2004 Mar;3(1):97-104. doi: 10.2174/1568010043483944.
- Szekeres-Bartho J. The Role of Progesterone in Feto-Maternal Immunological Cross Talk. Med Princ Pract. 2018;27(4):301-307. doi: 10.1159/000491576. Epub 2018 Jun 27.
- Wang W, Sung N, Gilman-Sachs A, Kwak-Kim J. T Helper (Th) Cell Profiles in Pregnancy and Recurrent Pregnancy Losses: Th1/Th2/Th9/Th17/Th22/Tfh Cells. Front Immunol. 2020 Aug 18;11:2025. doi: 10.3389/fimmu.2020.02025. eCollection 2020.
- Raghupathy R, Szekeres-Bartho J. Progesterone: A Unique Hormone with Immunomodulatory Roles in Pregnancy. Int J Mol Sci. 2022 Jan 25;23(3):1333. doi: 10.3390/ijms23031333.
- Zhao Y, Zhang T, Guo X, Wong CK, Chen X, Chan YL, Wang CC, Laird S, Li TC. Successful implantation is associated with a transient increase in serum pro-inflammatory cytokine profile followed by a switch to anti-inflammatory cytokine profile prior to confirmation of pregnancy. Fertil Steril. 2021 Apr;115(4):1044-1053. doi: 10.1016/j.fertnstert.2020.10.031. Epub 2020 Nov 30.
- Murphy SP, Tayade C, Ashkar AA, Hatta K, Zhang J, Croy BA. Interferon gamma in successful pregnancies. Biol Reprod. 2009 May;80(5):848-59. doi: 10.1095/biolreprod.108.073353. Epub 2009 Jan 21.
- Chaouat G, Menu E, Clark DA, Dy M, Minkowski M, Wegmann TG. Control of fetal survival in CBA x DBA/2 mice by lymphokine therapy. J Reprod Fertil. 1990 Jul;89(2):447-58. doi: 10.1530/jrf.0.0890447.
- Xu WM, Xiao ZN, Wang XB, Huang Y. IL-17 Induces Fetal Loss in a CBA/JxBALB/c Mouse Model, and an Anti-IL-17 Antibody Prevents Fetal Loss in a CBA/JxDBA/2 Mouse Model. Am J Reprod Immunol. 2016 Jan;75(1):51-8. doi: 10.1111/aji.12437. Epub 2015 Oct 17.
- Kao LC, Tulac S, Lobo S, Imani B, Yang JP, Germeyer A, Osteen K, Taylor RN, Lessey BA, Giudice LC. Global gene profiling in human endometrium during the window of implantation. Endocrinology. 2002 Jun;143(6):2119-38. doi: 10.1210/endo.143.6.8885.
- Wu HX, Jin LP, Xu B, Liang SS, Li DJ. Decidual stromal cells recruit Th17 cells into decidua to promote proliferation and invasion of human trophoblast cells by secreting IL-17. Cell Mol Immunol. 2014 May;11(3):253-62. doi: 10.1038/cmi.2013.67. Epub 2014 Mar 17.
- Yang D, Dai F, Yuan M, Zheng Y, Liu S, Deng Z, Tan W, Chen L, Zhang Q, Zhao X, Cheng Y. Role of Transforming Growth Factor-beta1 in Regulating Fetal-Maternal Immune Tolerance in Normal and Pathological Pregnancy. Front Immunol. 2021 Aug 31;12:689181. doi: 10.3389/fimmu.2021.689181. eCollection 2021.
- Keskin DB, Allan DS, Rybalov B, Andzelm MM, Stern JN, Kopcow HD, Koopman LA, Strominger JL. TGFbeta promotes conversion of CD16+ peripheral blood NK cells into CD16- NK cells with similarities to decidual NK cells. Proc Natl Acad Sci U S A. 2007 Feb 27;104(9):3378-83. doi: 10.1073/pnas.0611098104. Epub 2007 Feb 20.
- Matalka KZ. The effect of estradiol, but not progesterone, on the production of cytokines in stimulated whole blood, is concentration-dependent. Neuro Endocrinol Lett. 2003 Jun-Aug;24(3-4):185-91.
- Bourdon M, Santulli P, Jeljeli M, Vannuccini S, Marcellin L, Doridot L, Petraglia F, Batteux F, Chapron C. Immunological changes associated with adenomyosis: a systematic review. Hum Reprod Update. 2021 Jan 4;27(1):108-129. doi: 10.1093/humupd/dmaa038.
- Conrad KP, Baker VL. Corpus luteal contribution to maternal pregnancy physiology and outcomes in assisted reproductive technologies. Am J Physiol Regul Integr Comp Physiol. 2013 Jan 15;304(2):R69-72. doi: 10.1152/ajpregu.00239.2012. Epub 2012 Oct 24.
- Chen JZ, Sheehan PM, Brennecke SP, Keogh RJ. Vessel remodelling, pregnancy hormones and extravillous trophoblast function. Mol Cell Endocrinol. 2012 Feb 26;349(2):138-44. doi: 10.1016/j.mce.2011.10.014. Epub 2011 Oct 25.
- Labarta E, Mariani G, Paolelli S, Rodriguez-Varela C, Vidal C, Giles J, Bellver J, Cruz F, Marzal A, Celada P, Olmo I, Alama P, Remohi J, Bosch E. Impact of low serum progesterone levels on the day of embryo transfer on pregnancy outcome: a prospective cohort study in artificial cycles with vaginal progesterone. Hum Reprod. 2021 Feb 18;36(3):683-692. doi: 10.1093/humrep/deaa322.
- Labarta E, Sebastian-Leon P, Devesa-Peiro A, Celada P, Vidal C, Giles J, Rodriguez-Varela C, Bosch E, Diaz-Gimeno P. Analysis of serum and endometrial progesterone in determining endometrial receptivity. Hum Reprod. 2021 Oct 18;36(11):2861-2870. doi: 10.1093/humrep/deab184.
- Abdala A, Elkhatib I, Bayram A, Arnanz A, El-Damen A, Melado L, Lawrenz B, Fatemi HM, De Munck N. Day 5 vs day 6 single euploid blastocyst frozen embryo transfers: which variables do have an impact on the clinical pregnancy rates? J Assist Reprod Genet. 2022 Feb;39(2):379-388. doi: 10.1007/s10815-021-02380-1. Epub 2022 Jan 22.
- Munro MG, Critchley HOD, Fraser IS; FIGO Menstrual Disorders Committee. The two FIGO systems for normal and abnormal uterine bleeding symptoms and classification of causes of abnormal uterine bleeding in the reproductive years: 2018 revisions. Int J Gynaecol Obstet. 2018 Dec;143(3):393-408. doi: 10.1002/ijgo.12666. Epub 2018 Oct 10. Erratum In: Int J Gynaecol Obstet. 2019 Feb;144(2):237.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Genital Diseases
- Genital Diseases, Female
- Infertility
- Infertility, Female
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Estrogens
- Contraceptive Agents, Hormonal
- Contraceptive Agents
- Reproductive Control Agents
- Contraceptive Agents, Female
- Progestins
- Estradiol
- Progesterone
- Estradiol 17 beta-cypionate
- Estradiol 3-benzoate
- Polyestradiol phosphate
Other Study ID Numbers
- 2206-ABU-004-LMM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Infertility, Female
-
Esraa Gamal AhmedAin Shams Maternity HospitalUnknownUnexplained Female Infertility
-
Pacific Fertility CenterTerminatedPrimary Female Infertility | Secondary Female Infertility
-
Assuta Hospital SystemsMaccabi Healthcare Services, IsraelCompletedInfertility, Female Infertility, Male InfertilityIsrael
-
Newlife Fertility CentreRecruitingInfertility | Infertility,Female | Infertility Unexplained | Infertility of Uterine Origin | Infertility; Female, NonimplantationCanada
-
Cairo UniversityCompleted
-
Navy General Hospital, BeijingUnknownFemale Infertility Due to Nonimplantation of OvumChina
-
Wake Forest University Health SciencesWithdrawnUterine Diseases | Endometriosis | Infertility Unexplained | Endometrial Diseases | Infertility; Female, NonimplantationUnited States
-
Sapientiae InstituteTerminated
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompletedPregnancy | Male Infertility | Female InfertilityNetherlands
-
Woman's Health University Hospital, EgyptCompletedFemale Infertility Due to Diminished Ovarian ReserveEgypt
Clinical Trials on Endometrin 100Mg Vaginal Insert
-
Wolfson Medical CenterUnknown
-
CONRADCompletedVaginal DiseasesUnited States
-
Ferring PharmaceuticalsCompletedCervical Ripening | Labor InductionUnited Kingdom
-
Eastern Virginia Medical SchoolUniversity of Pittsburgh; United States Agency for International Development... and other collaboratorsRecruitingSafety IssuesUnited States, Kenya, South Africa
-
Yale UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedPolycystic Ovarian SyndromeUnited States
-
Meir Medical CenterUnknownReproductive Behavior
-
Ferring PharmaceuticalsCompletedLabor, Induced | Cervical RipeningUnited States, Canada
-
EndoCeutics Inc.CompletedHypoactive Sexual Desire DisorderUnited States, Canada
-
EndoCeutics Inc.AMAG Pharmaceuticals, Inc.WithdrawnHypoactive Sexual Desire Disorder (HSDD)United States
-
CONRADUnited States Agency for International Development (USAID); Eastern Virginia...Completed