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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Subfertility, Female Ovulation Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Diphereline (Triptorelin embonate)

Intervention Type DRUG

human menopausal gonadotropin

Intervention Type DRUG

human chorionic gonadotropin

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Decapeptyl (Triptorelin)

Intervention Type DRUG

human menopausal gonadotropin

Intervention Type DRUG

human chorionic gonadotropin

Intervention Type DRUG

Interventions

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Diphereline (Triptorelin embonate)

Intervention Type DRUG

Decapeptyl (Triptorelin)

Intervention Type DRUG

human menopausal gonadotropin

Intervention Type DRUG

human chorionic gonadotropin

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

35 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Yunhai Chuai

Department of Obstetrics and Gynecology, Navy General Hospital, Beijing

Responsibility Role PRINCIPAL_INVESTIGATOR