Success Rate Natural Cycles Versus Modified Natural Cycles in Frozen Embryos

Infertility, Female Clinical Trial

Official title:

Comparison of Clinical Results of Frozen Embryo Transfer in Natural and Modified Natural Cycles

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03798886
• Other study ID #: ATADEK-2018/20
• Status: Active, not recruiting
• Start date: January 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: March 2019
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility
• Infertility, Female

Intervention

Other:
• natural cycle
When follicle is ready for ovulation, we will use this injection by intra-dermal route
• modified natural cycle
we will use that drug in the natural modified transfer group after embryo transfer
• embryo transfer
we will do transfer when the endometrium is ready

Locations

Country	Name	City	State
Turkey	Acibadem MAA University Atakent Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Acibadem University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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: — View 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. Review. Erratum in: Hum Reprod Update. 2017 Mar 1;23(2):255-261. — View 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, 2 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	birth	live birth	bigger than 24 weeks pregnancy
Secondary	pregnancy rate	hcg blood test	10th day after embryo transfer
Secondary	clinical pregnancy rate	positive fetal cardiac activity	8 weeks
Secondary	abortion rate	abortion after visualization of fetal cardiac activity	8 weeks