Efficacy and Safety of Crinone Versus Combination Medication (ACCESS)

Infertility Clinical Trial

Official title:

Comparison of Crinone ® Versus Combination Medication for Luteal Phase Support on the Ongoing Pregnancy Rate of Frozen-thawed Cycle in Chinese Population a Randomized, Interventional, Open-label, Phase IV, Single Center, Pilot Study (ACCESS)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03858049
• Other study ID #: MS200113_0005
• Status: Terminated
• Phase: Phase 4
• Start date: May 31, 2019
• Est. completion date: October 27, 2021

Study information

• Verified date: August 2023
• Source: Merck KGaA, Darmstadt, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 172
• Est. completion date: October 27, 2021
• Est. primary completion date: October 27, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA, Darmstadt, Germany	Merck Serono Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Beta Human Chorionic Gonadotrophin (Beta-hCG) Positive Rate	Beta-hCG positive rate defined as number of participants with positive beta-hCG divided by the number of participants with embryo transfer (ET) multiplied by 100.	2 weeks after embryo transfer
Secondary	Implantation Rate	Implantation rate was measured as the number of gestational sacs observed divided by the number of embryos transferred (ET) multiplied by 100.	4-6 weeks after embryo transfer
Secondary	Clinical Pregnancy Rate	Clinical Pregnancy was defined as the pregnancy diagnosed by ultrasound of one or more gestational sacs or definitive clinical signs of pregnancy. Clinical pregnancy rate was measured as the number of participants with clinical pregnancy divided by number of participants with embryo transfer (ET) multiplied by 100.	4-6 weeks after embryo transfer
Secondary	Early Abortion Rate	Early abortion defined as the spontaneous loss of an intra-uterine pregnancy prior to 12 completed weeks of gestational age. Early abortion rate defined as the number of participants with early abortion divided by number of participants with clinical pregnancy multiplied by 100.	Time from embryo transfer to 12 weeks of pregnancy
Secondary	Luteal Phase Bleeding Rate	Luteal Phase Bleeding defined as the onset of any bleeding after embryo transfer and prior to the pregnancy test. Luteal phase bleeding rate defined as the number of participants with Luteal phase bleeding divided by number of participants with embryo transfer (ET) multiplied by 100.	2, 5 and 9 weeks after embryo transfer
Secondary	Vaginal Bleeding Rate	Vaginal bleeding is defined as any bleeding recorded after a pregnancy test via serum Beta-Human Chorionic Gonadotrophin. Vaginal bleeding rate defined as the number of participants with vaginal bleeding divided by number of participants with embryo transfer (ET) multiplied by 100.	5 and 9 weeks after embryo transfer

External Links

•   Trial Awareness and Transparency website