Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)

  • STATUS
    Recruiting
  • End date
    Dec 4, 2022
  • participants needed
    334
  • sponsor
    Merck KGaA, Darmstadt, Germany
Updated on 16 July 2021
cavities
estradiol
embryo transfer
crinone

Summary

The study to compare to the efficacy and safety of Crinone versus combination medication in infertile women receive frozen-thawed embryo transfer (FET) in artificial cycles (AC).

Details
Condition Female Genital Diseases, Infertility, Gynecological Infections, sterility, unable to conceive
Treatment Crinone, Duphaston, Duphaston
Clinical Study IdentifierNCT03858049
SponsorMerck KGaA, Darmstadt, Germany
Last Modified on16 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants are eligible to be included in the study only if all the
following criteria
apply
Participants who will receive artificial frozen-thawed embryo transfer (FET) cycle study interventions
Participants who have no more than two Day 5 embryos are planned to be transferred (follow the clinical practice of the study site)
Participants have received estradiol valerate for no more than 20 days
Participants have a transitional-endometrium of greater than or equal to 8 millimeter
Participants have normal uterine cavity
Participants can give signed informed consent
Participants are willing to follow the study protocol and able to complete the study

Exclusion Criteria

Participants are willing to follow the study protocol and able to complete the study
Participants with greater than or equal to three previously failed cycles of ET
Participants with diseases that cannot tolerate pregnancy
Hydrosalpinx
Severe endometriosis (Endometriosis American Society for Reproductive Medicine (ASRM) criteria from 1996)
Known hypersensitivity to progesterone, the excipients of Crinone and Duphaston Vaginal bleeding of unknown origin
History of recurrent miscarriages
Vaginitis
Thromboembolic diseases (thrombophlebitis, thromboembolic disorder, or cerebral apoplexy) or participants with a history of these conditions
Known or suspected progestogen-dependent neoplasm
Participation in another clinical trial within the past 30 days
Contraindications of both Crinone and Duphaston
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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