Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

172 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-31

Study Completion Date

2021-10-27

Brief Summary

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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).

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Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Crinone

Participants received Crinone 8% (90 milligrams \[mg\] an intravaginal progesterone gel contained in a single use, one piece applicator) once daily in morning from the day of endometrial transformation (Day -5) until ongoing pregnancy was confirmed up to Day 63.

Group Type EXPERIMENTAL

Crinone

Intervention Type DRUG

Participants received Crinone 8% (90 milligrams \[mg\] an intravaginal progesterone gel contained in a single use, one piece applicator) once daily in morning from the day of endometrial transformation (Day -5) until ongoing pregnancy was confirmed up to Day 63.

Crinone plus Duphaston

Participants received Crinone 8% (90 mg an intravaginal progesterone gel contained in a single use, one piece applicator) once daily in morning followed by 10 mg of Duphaston tablet orally twice a day from the day of endometrial transformation (Day -5) until ongoing pregnancy was confirmed up to Day 63.

Group Type EXPERIMENTAL

Crinone

Intervention Type DRUG

Participants received Crinone 8% (90 milligrams \[mg\] an intravaginal progesterone gel contained in a single use, one piece applicator) once daily in morning from the day of endometrial transformation (Day -5) until ongoing pregnancy was confirmed up to Day 63.

Duphaston

Intervention Type DRUG

Participants received 10 mg of Duphaston tablet orally twice a day from the day of endometrial transformation (Day -5) until ongoign pregnancy was confirmed up to Day 63.

Interventions

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Crinone

Participants received Crinone 8% (90 milligrams \[mg\] an intravaginal progesterone gel contained in a single use, one piece applicator) once daily in morning from the day of endometrial transformation (Day -5) until ongoing pregnancy was confirmed up to Day 63.

Intervention Type DRUG

Duphaston

Participants received 10 mg of Duphaston tablet orally twice a day from the day of endometrial transformation (Day -5) until ongoign pregnancy was confirmed up to Day 63.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No