Success Rate Natural Cycles Versus Modified Natural Cycles in Frozen Embryos

NCT03798886 | Unknown

• 1 other identifier: ATADEK-2018/20
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Infertility, Female

Keywords

Frozen embryo replacement, IVF success, ovarian stimulation

Outcome Measures

Primary Outcomes (1)

• birth

  live birth

  bigger than 24 weeks pregnancy

Secondary Outcomes (3)

• pregnancy rate

  10th day after embryo transfer

• clinical pregnancy rate

  8 weeks

• abortion rate

  8 weeks

Study Arms (2)

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; Other: modified natural cycle; Other: 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; Other: modified natural cycle; Other: embryo transfer

Interventions

natural cycle OTHER

When follicle is ready for ovulation, we will use this injection by intra-dermal route

Also known as: natural LH surge

Natural frozen embryo transfer group; modified natural embryo transfer group

modified natural cycle OTHER

we will use that drug in the natural modified transfer group after embryo transfer

Also known as: recombinant hcg

Natural frozen embryo transfer group; modified natural embryo transfer group

embryo transfer OTHER

we will do transfer when the endometrium is ready

Also known as: frozen embryo transfer

Natural frozen embryo transfer group; modified natural embryo transfer group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: woman who is infertile at reproductive age
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Acibadem University: lead

Study Sites (1)

Acibadem MAA University Atakent Hospital

Istanbul, 34457, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 21840758 BACKGROUND

• 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.

  PMID: 23820515 BACKGROUND

• 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.

  PMID: 25069504 RESULT

• 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.

  PMID: 20097333 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Patient blood sample for hormonal assay

MeSH Terms

Conditions

Infertility, Female

Interventions

Embryo Transfer

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Turgut Aydın

  acıbadem university atakent hospital

  STUDY DIRECTOR

• Elif Ganime Aydeniz

  acıbadem university atakent hospital

  STUDY CHAIR

• Emine Karabük

  acıbadem university atakent hospital

  STUDY CHAIR

• Burak Yücel

  Kanuni Sultan SüleymanHospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2019
• First Posted: January 10, 2019
• Study Start: January 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

TU (1)