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Success Rate Natural Cycles Versus Modified Natural Cycles in Frozen Embryos

Sponsor
Acibadem University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03798886
Collaborator
(none)
100
Enrollment
1
Location
23
Anticipated Duration (Months)
4.4
Patients Per Site Per Month

Study Details

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 Phase
  • 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 :
Jan 1, 2018
Anticipated Primary Completion Date :
Dec 1, 2019
Anticipated Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm 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 Names:
  • natural LH surge

    • Other: modified natural cycle
    we will use that drug in the natural modified transfer group after embryo transfer
    Other Names:
  • recombinant hcg

    • Other: embryo transfer
    we will do transfer when the endometrium is ready
    Other Names:
  • 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 Names:
  • natural LH surge

    • Other: modified natural cycle
    we will use that drug in the natural modified transfer group after embryo transfer
    Other Names:
  • recombinant hcg

    • Other: embryo transfer
    we will do transfer when the endometrium is ready
    Other Names:
  • frozen embryo transfer

    		•

    Outcome Measures

    Primary Outcome Measures

    1. birth [bigger than 24 weeks pregnancy]

      live birth

    Secondary Outcome Measures

    1. pregnancy rate [10th day after embryo transfer]

      hcg blood test

    2. clinical pregnancy rate [8 weeks]

      positive fetal cardiac activity

    3. abortion rate [8 weeks]

      abortion after visualization of fetal cardiac activity

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Acibadem University
    ClinicalTrials.gov Identifier:
    NCT03798886
    Other Study ID Numbers:
    • ATADEK-2018/20
    First Posted:
    Jan 10, 2019
    Last Update Posted:
    Mar 13, 2019
    Last Verified:
    Mar 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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

    Study Results

    No Results Posted as of Mar 13, 2019