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

Primary Purpose

Subfertility, Female, Ovulation Disorder

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Diphereline (Triptorelin embonate)

Decapeptyl (Triptorelin)

human menopausal gonadotropin

human chorionic gonadotropin

About this trial

This is an interventional treatment trial for Subfertility, Female

Eligibility Criteria

35 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Navy General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Low Dose GnRHa

GnRHa Ultra-short Protocol

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

clinical pregnancy rate

Presence of fetal heart at transvaginal ultrasound at 6 weeks of gestation or 6 weeks after starting the intervention.

Full Information

NCT ID

NCT02940535

First Posted

August 1, 2016

Last Updated

October 19, 2016

Sponsor

Navy General Hospital, Beijing

1. Study Identification

Unique Protocol Identification Number

NCT02940535

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (undefined)

Primary Completion Date

December 2019 (Anticipated)

Study Completion Date

December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Navy General Hospital, Beijing

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Subfertility, Female, Ovulation Disorder

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Low Dose GnRHa

Arm Type

Experimental

Arm Description

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.

Arm Title

GnRHa Ultra-short Protocol

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

Diphereline (Triptorelin embonate)

Intervention Type

Drug

Intervention Name(s)

Decapeptyl (Triptorelin)

Intervention Type

Drug

Intervention Name(s)

human menopausal gonadotropin

Intervention Type

Drug

Intervention Name(s)

human chorionic gonadotropin

Primary Outcome Measure Information:

Title

live birth

Description

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).

Time Frame

3 years

Secondary Outcome Measure Information:

Title

clinical pregnancy rate

Description

Presence of fetal heart at transvaginal ultrasound at 6 weeks of gestation or 6 weeks after starting the intervention.

Time Frame

3 years

Other Pre-specified Outcome Measures:

Title

multiple pregnancy

Description

The condition of carrying two or more FETUSES.

Time Frame

3 years

Title

miscarriage

Description

Expulsion of the product of FERTILIZATION before completing the term of GESTATION and without deliberate interference.

Time Frame

3 years

Title

Ectopic pregnancy

Description

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).

Time Frame

3 years

Title

Dose of HMG required

Time Frame

3 years

Title

Duration of HMG stimulation

Time Frame

3 years

Title

Number of oocytes retrieved

Time Frame

3 years

Title

Number of embryos obtained

Time Frame

3 years

Title

Number of embryos frozen

Time Frame

3 years

Title

Adverse effects

Description

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).

Time Frame

3 years

Title

Congenital Abnormalities

Description

Malformations of organs or body parts during development in utero.

Time Frame

3 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Wei Shang, Dr

shang.wei@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Wei Shang, Dr

Organizational Affiliation

Navy General Hospital, Beijing

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yunhai Chuai, Dr

Organizational Affiliation

Navy General Hospital, Beijing

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mingming Shu, Dr

Organizational Affiliation

Navy General Hospital, Beijing

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ming Zhou, Dr

Organizational Affiliation

Navy General Hospital, Beijing

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Huiming Han, Dr

Organizational Affiliation

Navy General Hospital, Beijing

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Mengnan Chen, Dr

Organizational Affiliation

Navy General Hospital, Beijing

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Lei Chen

Organizational Affiliation

Navy General Hospital, Beijing

Official's Role

Principal Investigator

Facility Information:

Facility Name

Navy General Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100048

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yunhai Chuai, Dr

Phone

+86-18810892004

wangyh85@foxmail.com

12. IPD Sharing Statement

Plan to Share IPD

Yes

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

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