Success Rate Natural Cycles Versus Modified Natural Cycles in Frozen Embryos

NCT ID: NCT03798886

Last Updated: 2019-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2019-12-01

Brief Summary

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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

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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

Conditions

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Infertility, Female

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

natural cycle

Intervention Type OTHER

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

modified natural cycle

Intervention Type OTHER

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

embryo transfer

Intervention Type OTHER

we will do transfer when the endometrium is ready

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.

natural cycle

Intervention Type OTHER

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

modified natural cycle

Intervention Type OTHER

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

embryo transfer

Intervention Type OTHER

we will do transfer when the endometrium is ready

Interventions

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natural cycle

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

Intervention Type OTHER

modified natural cycle

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

Intervention Type OTHER

embryo transfer

we will do transfer when the endometrium is ready

Intervention Type OTHER

Other Intervention Names

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natural LH surge recombinant hcg frozen embryo transfer

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Acibadem University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Turgut Aydın

Role: STUDY_DIRECTOR

acıbadem university atakent hospital

Elif Ganime Aydeniz

Role: STUDY_CHAIR

acıbadem university atakent hospital

Emine Karabük

Role: STUDY_CHAIR

acıbadem university atakent hospital

Burak Yücel

Role: STUDY_CHAIR

Kanuni Sultan SüleymanHospital

Locations

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Acibadem MAA University Atakent Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 21840758 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23820515 (View on PubMed)

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.

Reference Type RESULT
PMID: 25069504 (View on PubMed)

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.

Reference Type RESULT
PMID: 20097333 (View on PubMed)

Other Identifiers

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ATADEK-2018/20

Identifier Type: -

Identifier Source: org_study_id

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