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

Study Overview
=================
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.

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

Conditions
-----------------
Subfertility, Female, Ovulation Disorder

Intervention / Treatment
-----------------
* Drug: Diphereline (Triptorelin embonate)
* Drug: Decapeptyl (Triptorelin)
* Drug: human menopausal gonadotropin
* Drug: human chorionic gonadotropin


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Dose GnRHa<br>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)<br> <br> Drug: human menopausal gonadotropin<br> <br> Drug: human chorionic gonadotropin<br> <br> |
| Active Comparator: GnRHa Ultra-short Protocol<br>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: Decapeptyl (Triptorelin)<br> <br> Drug: human menopausal gonadotropin<br> <br> Drug: human chorionic gonadotropin<br> <br> |

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 |