Overview

Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)

Status:
Recruiting
Trial end date:
2022-12-04
Target enrollment:
0
Participant gender:
Female
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Merck KGaA, Darmstadt, Germany
Collaborators:
Merck Serono Co., Ltd.
Merck Serono Co., Ltd., Beijing, China
Treatments:
Dydrogesterone
Progesterone
Criteria
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