Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)

NCT03858049 | Terminated Phase 4 Results

• 1 other identifier: MS200113_0005
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Infertility

Keywords

Frozen-thawed embryo transfer; Infertility; Crinone; Duphaston; Chinese population

Outcome Measures

Primary Outcomes (1)

• Ongoing Pregnancy Rate

  Ongoing pregnancy was assessed by the presence of viable intra uterine fetus detected by ultrasound examination in 10-12 weeks of pregnancy (8 to 10 weeks after embryo transfer). Ongoing pregnancy rate is defined as the number of participants with ongoing pregnancy divided by the number of participants with embryo transfer (ET) multiplied by 100.

  8 to 10 weeks after embryo transfer

Secondary Outcomes (6)

• Beta Human Chorionic Gonadotrophin (Beta-hCG) Positive Rate

  2 weeks after embryo transfer

• Implantation Rate

  4-6 weeks after embryo transfer

• Clinical Pregnancy Rate

  4-6 weeks after embryo transfer

• Early Abortion Rate

  Time from embryo transfer to 12 weeks of pregnancy

• Luteal Phase Bleeding Rate

  2, 5 and 9 weeks after embryo transfer

Study Arms (2)

Crinone

EXPERIMENTAL

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.

Drug: Crinone

Crinone plus Duphaston

EXPERIMENTAL

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.

Drug: Crinone; Drug: Duphaston

Interventions

Crinone 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; Crinone plus Duphaston

Duphaston 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.

Crinone plus Duphaston

Eligibility Criteria

• Age: 20 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Peking University Third Hospital

Beijing, 100191, China

Location

Related Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

MeSH Terms

Conditions

Infertility

Interventions

Crinone; Dydrogesterone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Communication Center
• Organization: Merck KGaA, Darmstadt, Germany

service@emdgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: February 28, 2019
• Study Start: May 31, 2019
• Primary Completion: October 27, 2021
• Study Completion: October 27, 2021
• Last Updated: March 12, 2024
• Results First Posted: March 12, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Within six months after the approval of a new product or a new indication for an approved product in both the United States and the European Union
• Access Criteria: Qualified scientific and medical researchers can request the data. Such requests must be submitted in writing to the company's portal and will be internally reviewed regarding criteria for researchers' qualification and legitimacy of the research proposal.

Locations

CN (1)