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

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

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.

Study Overview

• Status: Unknown
• Conditions: Subfertility, Female; Ovulation Disorder
• Intervention / Treatment: Drug: Diphereline (Triptorelin embonate); Drug: human menopausal gonadotropin; Drug: human chorionic gonadotropin; Drug: Decapeptyl (Triptorelin)

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wei Shang, Dr; Email: shang.wei@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100048
      • Navy General Hospital
      • Contact: Yunhai Chuai, Dr; Phone Number: +86-18810892004; Email: wangyh85@foxmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low Dose GnRHa; Diphereline 0.375mg was administered in the early-luteal-phase. Human menopausal gonadotropin/human chorionic gonadotropin (HMG/HCG) was administered start in the day 28.	Drug: Diphereline (Triptorelin embonate); Drug: human menopausal gonadotropin; Drug: human chorionic gonadotropin
Active Comparator: GnRHa Ultra-short Protocol; Decapeptyl 0.1mg was administered in the menstrual day 2 to 7. Human menopausal gonadotropin/human chorionic gonadotropin (HMG/HCG) was administered start in the menstrual day 2.	Drug: human menopausal gonadotropin; Drug: human chorionic gonadotropin; Drug: Decapeptyl (Triptorelin)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical pregnancy rate	Presence of fetal heart at transvaginal ultrasound at 6 weeks of gestation or 6 weeks after starting the intervention.	3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
multiple pregnancy	The condition of carrying two or more FETUSES.	3 years
miscarriage	Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference.	3 years
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
Dose of HMG required		3 years
Duration of HMG stimulation		3 years
Number of oocytes retrieved		3 years
Number of embryos obtained		3 years
Number of embryos frozen		3 years
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
Congenital Abnormalities	Malformations of organs or body parts during development in utero.	3 years

Collaborators and Investigators

• Sponsor: Navy General Hospital, Beijing
• Investigators: Principal Investigator: Wei Shang, Dr, Navy General Hospital, Beijing; Principal Investigator: Mingming Shu, Dr, Navy General Hospital, Beijing; Principal Investigator: Ming Zhou, Dr, Navy General Hospital, Beijing; Principal Investigator: Huiming Han, Dr, Navy General Hospital, Beijing; Principal Investigator: Mengnan Chen, Dr, Navy General Hospital, Beijing; Principal Investigator: Lei Chen, Navy General Hospital, Beijing

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: August 1, 2016
• First Submitted That Met QC Criteria: October 19, 2016
• First Posted (Estimate): October 21, 2016

Study Record Updates

• Last Update Posted (Estimate): October 21, 2016
• Last Update Submitted That Met QC Criteria: October 19, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility; Infertility, Female; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptive Agents, Female; Fertility Agents, Female; Fertility Agents; Luteolytic Agents; Triptorelin Pamoate; Chorionic Gonadotropin; Menotropins
• Other Study ID Numbers: SW001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes