Clinical trial NCT03798886: Success Rate Natural Cycles Versus Modified Natural Cycles in Frozen Embryos
Official title: Comparison of Clinical Results of Frozen Embryo Transfer in Natural and Modified Natural Cycles
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility, Female
Keywords: Frozen embryo replacement, IVF success, ovarian stimulation
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study will bw carried out as a prospective randomized clinical trial on regular menstruating patients arriving for transfer of frozen embryo to the center in a single IVF center. Results will collected and recorded daily during the study. With 80% power analysis minimum number of patients 0.05% significance level is 240.

Study will be designed in 1 year.

Brief summary: There has been a recent significant increase in the frozen embryo replacement (FER) cycles due to freeze-all cycles to decrease the risk of ovarian hyperstimulation syndrome. Now a days making frozen embryo transfers (FETs) a viable alternative to fresh embryo transfer

Detailed description: There has been a recent significant increase in the frozen embryo replacement (FER) cycles due to freeze-all cycles to decrease the risk of ovarian hyperstimulation syndrome. Now a days making frozen embryo transfers (FETs) a viable alternative to fresh embryo transfer, with reports from observational studies and randomized controlled trials suggesting that:

1. The endometrium in stimulated cycles is not optimal for implantation
2. Pregnancy rates are increased following FET
3. Perinatal outcomes are less affected after FET
4. Preimplantation genetic screening We will follow only natural and modified natural cycles patients. Spontaneous ovulation will documented with hormonal and sonographic monitoring. Hormonal monitoring are including estradiol and luteinizing hormone (LH). Sonographic monitoring is including follicule diameter (16-20 mm). At modified natural cycles we will use hCG triggering for ovulation approximately 16-20 mm diameter.

We will compare success rate between natural and modified natural cycles

Eligibility criteria: Inclusion Criteria:

* Patient who are admitted to the IVF center and who will be transferred to frozen embryos.
* Infertile women under 40 years of age who accepted this study.
* Unexplained infertilite couple.
* All ovulatory patient.
* Male factor.
* Tubal factor.

Exclusion Criteria:

* Patients who made intrauterin surgery.
* Over 40 years of age women.
* Patients with preimplantation genetic diagnosis.
* Anovulatory patient.

Primary outcomes:
measure: birth
timeFrame: bigger than 24 weeks pregnancy
Secondary outcomes:
measure: pregnancy rate
timeFrame: 10th day after embryo transfer
measure: clinical pregnancy rate
timeFrame: 8 weeks
measure: abortion rate
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem MAA University Atakent Hospital
Study officials:
affiliation: acıbadem university atakent hospital
name: Turgut Aydın
role: STUDY_DIRECTOR
affiliation: acıbadem university atakent hospital
name: Elif Ganime Aydeniz
role: STUDY_CHAIR
affiliation: acıbadem university atakent hospital
name: Emine Karabük
role: STUDY_CHAIR
affiliation: Kanuni Sultan SüleymanHospital
name: Burak Yücel
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: Kupka MS, Ferraretti AP, de Mouzon J, Erb K, D'Hooghe T, Castilla JA, Calhaz-Jorge C, De Geyter C, Goossens V; European IVF-Monitoring Consortium, for the European Society of Human Reproduction and Embryology. Assisted reproductive technology in Europe, 2010: results generated from European registers by ESHREdagger. Hum Reprod. 2014 Oct 10;29(10):2099-113. doi: 10.1093/humrep/deu175. Epub 2014 Jul 27.
citation: 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.