Low Dose GnRHa Early Luteal Phase Down Regulation Versus GnRHa Ultra-short Protocol for Poor Ovarian Response

Ovulation Disorder Clinical Trial

Official title:

Low Dose GnRHa Early Luteal Phase Down Regulation Versus GnRHa Ultra-short Protocol for Poor Ovarian Response: a Randomized Control Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02940535
• Other study ID #: SW001
• Status: Not yet recruiting
• Phase: N/A
• First received: August 1, 2016
• Last updated: October 19, 2016
• Start date: December 2016
• Est. completion date: December 2020

Study information

• Verified date: October 2016
• Source: Navy General Hospital, Beijing
• Contact: Wei Shang, Dr
• Email: shang.wei[@]163.com
• Is FDA regulated: No
• Health authority: China: National Natural Science FoundationChina: Ministry of Science and Technology
• Study type: Interventional

Clinical Trial Summary

The management of the poor responder patients is very difficult. Currently, there is no any standard treatment for poor responder patients. The study is designed to test a modified GnRHa protocol for poor ovarian response, low dose GnRHa early luteal phase down regulation, compare with GnRHa ultra-short protocol. This is a randomized controlled trial.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 45 Years

Eligibility

Inclusion Criteria:

• At least two of the following three features must be present: i. Advanced maternal age (=40 years) or any other risk factor for POR (poor ovarian response); ii. A previous POR (=3 oocytes with a conventional stimulation protocol); iii. An abnormal ovarian reserve test (i.e. AFC <7 follicles or AMH <1.1 ng/ml).

Exclusion Criteria:

• Contraindications for IVF/ICSI

• Contraindications for pregnancy

• Primary ovarian insufficiency

• AFC <3

• PGD/PGS

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Ovulation Disorder
• Subfertility, Female

Intervention

Drug:
• Diphereline (Triptorelin embonate)

• Decapeptyl (Triptorelin)

• human menopausal gonadotropin

• human chorionic gonadotropin

Locations

Country	Name	City	State
China	Navy General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Navy General Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	multiple pregnancy	The condition of carrying two or more FETUSES.	3 years	Yes
Other	miscarriage	Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference.	3 years	Yes
Other	Ectopic pregnancy	A potentially life-threatening condition in which EMBRYO IMPLANTATION occurs outside the cavity of the UTERUS. Most ectopic pregnancies (>96%) occur in the FALLOPIAN TUBES, known as TUBAL PREGNANCY. They can be in other locations, such as UTERINE CERVIX; OVARY; and abdominal cavity (PREGNANCY, ABDOMINAL).	3 years	Yes
Other	Dose of HMG required		3 years	Yes
Other	Duration of HMG stimulation		3 years	Yes
Other	Number of oocytes retrieved		3 years	No
Other	Number of embryos obtained		3 years	No
Other	Number of embryos frozen		3 years	No
Other	Adverse effects	According to the Common Terminology Criteria for Adverse Events, version 4.0 (CTCAE 2009). Some adverse events will be studied as separate outcomes, including ovarian hyperstimulation syndrome (OHSS).	3 years	Yes
Other	Congenital Abnormalities	Malformations of organs or body parts during development in utero.	3 years	Yes
Primary	live birth	The event that a FETUS is born alive with heartbeats or RESPIRATION regardless of GESTATIONAL AGE. Such liveborn is called a newborn infant (INFANT, NEWBORN).	3 years	No
Secondary	clinical pregnancy rate	Presence of fetal heart at transvaginal ultrasound at 6 weeks of gestation or 6 weeks after starting the intervention.	3 years	No