Two Different Types of Luteal Phase Support in Natural Cycle Frozen Embryo Transfer and Its Effect on Pregnancy Rates
NCT ID: NCT05838105
Last Updated: 2023-05-01
Study Results
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Basic Information
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UNKNOWN
NA
144 participants
INTERVENTIONAL
2022-10-01
2025-01-01
Brief Summary
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Detailed Description
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There are different methods to prepare the endometrium for FET:
1. Natural cycle (NC) - natural preparation of the body for implantation without the need for medicinal intervention.
2. Modified natural cycle (mNC) - Inducing ovulation by administration of Human Chorionic Gonadotropin (HCG) trigger.
3. Medical - preparation of endometrium with hormones (estrogen and progesterone).
Following embryo transfer, luteal phase support should be considered. Administration of treatment depends on the type of cycle chosen (either natural or medicated). Treatment options include progesterone, HCG and Gonadotropin Releasing Hormone (GnRH) analog - either one of them or combined. Different protocols (dosages and duration of use) with different pregnancy outcomes were explore before with inconclusive results. We wish to investigate administration of GnRH agonist+HCG vs. progesterone.
Patients included in the study will be women undergoing natural cycle FET at the IVF center in Shaare Zedek, Jerusalem, Israel. All patients will be randomly divided into two groups, each will receive a different luteal treatment support as will be detailed later. Patients demographic data and pregnancy outcomes will be collected.
Based on the clinical pregnancy rate in the prospective study by Bjuresten, et al \[Fertil Steril, 2011\], where a clinical pregnancy rate of 32% was found among women treated with progesterone for luteal support, and given an alpha of 5% and a power of 80%, 144 women (72 women in each group) are required in order to demonstrate a clinical pregnancy rate of 55% in the study group.
Comparison of categorical variables will be carried out using the the chi-squared test. Comparison of continuous variables will be performed using the Students t-Test or Mann-Whitney U method depending on the variable distribution (normal vs. non-normal distribution, respectively). A multivariate regression will also be conducted in order to determine which variables are significantly and independently related. Statistical significance will be defined when P values are less than 0.05
Conditions
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Study Design
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RANDOMIZED
PARALLEL
1. Study group - patients will receive luteal support with GNRH agonist and HCG according to departmental protocol (described later).
2. Control group - patients will receive luteal support with vaginal progesterone.
TREATMENT
NONE
Study Groups
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Study group
Patients will receive luteal support with GNRH agonist and HCG according to departmental protocol:
Cleavage stage embryo:
* ET day (embryo day 2-3) - Ovitrelle 125mcg
* Day 3 after ET - Ovitrelle 125mcg + Decapeptyl 0.1mg
* Day 6 after ET- Ovitrelle 125mcg
* Day 9 after ET - Ovitrelle 125mcg
Embryo blastocyst stage:
* ET day (embryo day 5-6) - Ovitrelle 125mcg + Decapeptyl 0.1mg
* Day 3 after ET - Ovitrelle 125mcg
* Day 6 after ET - Ovitrelle 125mcg
GnRH agonist
125 mcg once at the day mentioned
hCG
dose as mentioned
Control group
Patients will receive luteal support with vaginal progesterone - 100 mg Endometrin twice daily until week 8 of pregnancy.
Progesterone 100Mg Vag Tab
dose as mentioned
Interventions
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GnRH agonist
125 mcg once at the day mentioned
hCG
dose as mentioned
Progesterone 100Mg Vag Tab
dose as mentioned
Eligibility Criteria
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Inclusion Criteria
* Women undergoing frozen embryos transfer in a natural cycle
* Age 18-45
* BMI 18-35
Exclusion Criteria
* Women with a BMI over 35 or under 18.
* Women with hydrosalpinges
* Women with defects or uterine malformations (congenital) or acquired such as myomas
* Egg donation and surrogacy
* Use of preimplantation genetic testing
18 Years
45 Years
FEMALE
Yes
Sponsors
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Shaare Zedek Medical Center
OTHER
Responsible Party
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Heli Alexandroni
Alexandroni Heli
Principal Investigators
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Keren Rotshenker Olshnika, MD
Role: PRINCIPAL_INVESTIGATOR
Sharee Zedek Medical Center, Israel
Locations
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Shaare Zedek medical center
Jerusalem, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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Groenewoud ER, Cantineau AE, Kollen BJ, Macklon NS, Cohlen BJ. What is the optimal means of preparing the endometrium in frozen-thawed embryo transfer cycles? A systematic review and meta-analysis. Hum Reprod Update. 2013 Sep-Oct;19(5):458-70. doi: 10.1093/humupd/dmt030. Epub 2013 Jul 2.
Le Lannou D, Griveau JF, Laurent MC, Gueho A, Veron E, Morcel K. Contribution of embryo cryopreservation to elective single embryo transfer in IVF-ICSI. Reprod Biomed Online. 2006 Sep;13(3):368-75. doi: 10.1016/s1472-6483(10)61441-1.
Loutradi KE, Kolibianakis EM, Venetis CA, Papanikolaou EG, Pados G, Bontis I, Tarlatzis BC. Cryopreservation of human embryos by vitrification or slow freezing: a systematic review and meta-analysis. Fertil Steril. 2008 Jul;90(1):186-93. doi: 10.1016/j.fertnstert.2007.06.010. Epub 2007 Nov 5.
Weissman A, Horowitz E, Ravhon A, Steinfeld Z, Mutzafi R, Golan A, Levran D. Spontaneous ovulation versus HCG triggering for timing natural-cycle frozen-thawed embryo transfer: a randomized study. Reprod Biomed Online. 2011 Oct;23(4):484-9. doi: 10.1016/j.rbmo.2011.06.004. Epub 2011 Jun 15.
Mackens S, Stubbe A, Santos-Ribeiro S, Van Landuyt L, Racca A, Roelens C, Camus M, De Vos M, van de Vijver A, Tournaye H, Blockeel C. To trigger or not to trigger ovulation in a natural cycle for frozen embryo transfer: a randomized controlled trial. Hum Reprod. 2020 May 1;35(5):1073-1081. doi: 10.1093/humrep/deaa026.
Ghobara T, Gelbaya TA, Ayeleke RO. Cycle regimens for frozen-thawed embryo transfer. Cochrane Database Syst Rev. 2017 Jul 5;7(7):CD003414. doi: 10.1002/14651858.CD003414.pub3.
Montagut M, Santos-Ribeiro S, De Vos M, Polyzos NP, Drakopoulos P, Mackens S, van de Vijver A, van Landuyt L, Verheyen G, Tournaye H, Blockeel C. Frozen-thawed embryo transfers in natural cycles with spontaneous or induced ovulation: the search for the best protocol continues. Hum Reprod. 2016 Dec;31(12):2803-2810. doi: 10.1093/humrep/dew263. Epub 2016 Oct 25.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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LutealSupport
Identifier Type: -
Identifier Source: org_study_id
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