Success Rate Natural Cycles Versus Modified Natural Cycles in Frozen Embryos

• ClinicalTrials.gov Identifier: NCT03798886
• Recruitment Status: Unknown
• First Posted: January 10, 2019
• Last Update Posted: March 13, 2019
• Sponsor: Acibadem University
• Information provided by (Responsible Party): Acibadem University

Study Description

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

Condition or disease	Intervention/treatment
Infertility, Female	Other: natural cycle; Other: modified natural cycle; Other: 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

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Comparison of Clinical Results of Frozen Embryo Transfer in Natural and Modified Natural Cycles
• Actual Study Start Date: January 1, 2018
• Estimated Primary Completion Date: December 1, 2019
• Estimated Study Completion Date: December 1, 2019

Groups and Cohorts

Group/Cohort	Intervention/treatment
Natural frozen embryo transfer group; In this group all embryos will be frozen when transfer planned sonographic follicle diameter measured. After spontaneous ovulation, embryo transfer will be planned. Luteal phase support will not be used.	Other: natural cycle; When follicle is ready for ovulation, we will use this injection by intra-dermal route; Other Name: natural LH surge; Other: modified natural cycle; we will use that drug in the natural modified transfer group after embryo transfer; Other Name: recombinant hcg; Other: embryo transfer; we will do transfer when the endometrium is ready; Other Name: frozen embryo transfer
modified natural embryo transfer group; In this group all embryos will be frozen when transfer planned sonographic follicle diameter measured. When follicle diameter is 16-17 mm we will apply hCG (recombinant hCG). After ovulation, embryo transfer will be done. Luteal phase support will not be used.	Other: natural cycle; When follicle is ready for ovulation, we will use this injection by intra-dermal route; Other Name: natural LH surge; Other: modified natural cycle; we will use that drug in the natural modified transfer group after embryo transfer; Other Name: recombinant hcg; Other: embryo transfer; we will do transfer when the endometrium is ready; Other Name: frozen embryo transfer

Outcome Measures

Primary Outcome Measures :

1. birth [ Time Frame: bigger than 24 weeks pregnancy ]
   live birth

Secondary Outcome Measures :

1. pregnancy rate [ Time Frame: 10th day after embryo transfer ]
   hcg blood test
2. clinical pregnancy rate [ Time Frame: 8 weeks ]
   positive fetal cardiac activity
3. abortion rate [ Time Frame: 8 weeks ]
   abortion after visualization of fetal cardiac activity

Biospecimen Retention:   Samples Without DNA

Patient blood sample for hormonal assay

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes
• Gender Eligibility Description: woman who is infertile at reproductive age
• Accepts Healthy Volunteers: Yes
• 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.

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.

Contacts and Locations

Locations

Turkey

Acibadem MAA University Atakent Hospital

Istanbul, Turkey, 34457

Sponsors and Collaborators

Acibadem University

Investigators

• Study Director: Turgut Aydın; acıbadem university atakent hospital
• Study Chair: Elif Ganime Aydeniz; acıbadem university atakent hospital
• Study Chair: Emine Karabük; acıbadem university atakent hospital
• Study Chair: Burak Yücel; Kanuni Sultan SüleymanHospital

More Information

Publications of Results:

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 ESHRE†. Hum Reprod. 2014 Oct 10;29(10):2099-113. doi: 10.1093/humrep/deu175. Epub 2014 Jul 27.

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.

Other Publications:

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.

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.

• Responsible Party: Acibadem University
• ClinicalTrials.gov Identifier: NCT03798886
• Other Study ID Numbers: ATADEK-2018/20
• First Posted: January 10, 2019
• Last Update Posted: March 13, 2019
• Last Verified: March 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: We did not decide for this but if they need any information we can support all

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Acibadem University:

Frozen embryo replacement, IVF success, ovarian stimulation

Additional relevant MeSH terms:

Infertility; Infertility, Female