Purpose of Study 

Endometrium plays a major role in establishing a pregnancy and any alteration in this, could be a potential cause for failure of implantation thus affecting fertility. Endometrial factor is an important subset in infertility among women, Other treatments like, In-Vitro Fertilization (IVF) - Embryo Transfer (ET), Gamete Intra Fallopian Transfer (GIFT) etc are also available. But all these treatments require a healthy endometrium which is capable of implantation of embryo in mother’s womb.It is becoming clear that overcoming the current bottleneck in improvements to assisted reproductive techniques will require a closer look at the interface between uterus and embryo. Indeed, embryo implantation requires a cross talk with a receptive endometrium.Extended oestrogen treatment and adjuvant therapy, such as low dose aspirin, vaginal Sildenafil etc. are used in modern science for improving endometrium thickness but there isn’t any proved incidence for this treatment.There are many drawbacks in available modern treatment protocols, like unsatisfactory results, highly expensive and lots of side effects, frequent abortion, multiple gestations and major long term possibility of endometrial cancer.So, there is a great scope of research to find out safe, potent, less costly and effective remedies from Ayurveda classics for the management of Vandhyatva w.s.r. to Endometrial thickness. Here an effort in this direction has been put forward by this research work.

Hypothesis of Study :

Null Hypothesis: (H₀): Saubhagyanandana Ghrita Yonipeechu and Jeevaniya Churna orally is not effective in the management of Vandhyatva (female infertility) w.s.r to endometrium thickness?

Alternative Hypothesis (H₁) :Saubhagyanandana Ghrita Yonipeechu and Jeevaniya Churna orally is effective in the management of Vandhyatva (female infertility) w.s.r to endometrium thickness?

TREATMENT PROTOCOL:

Enrolled patients fulfilling the criteria will be given following treatment.

DRUG	DOSE	ROUTE	DURATION
Saubhagyanandana Ghrita	3-5ml once daily for 6 days	Intravaginal	1 cycle
Jeevaniya Churna	6 gm BD	Orally with Anupana of Milk	30 days

PATHYA-APATHYA

Pathya (do) and Apathya (don’ts) will be advised to the patients as per Prakriti, Kala etc.
 
WITHDRAWAL CRITERIA
Patient will be withdrawal from the study if any serious complication developed which requires urgent treatment during the study.
 
FOLLOW UP
After the completion of treatment, follow up study will be done for 1 month with the interval of 15 days.
CRITERIA OF ASSESSMENT:

SUBJECTIVE PARAMETER:  Subjective Parameter will be assessed where effect will be seen on the basis of changes at end point in comparison to base line score.It includes following parameters:

	Before treatment	After treatment	Follow Up
Regularity	Regular/Irregular	Regular/Irregular	Regular/Irregular
Quantity	Scanty/Moderate/ Excessive	Scanty/Moderate/ Excessive	Scanty/Moderate/ Excessive
Duration
Interval
Painful/painless:
Character of flow	clots/watery/ foul smelling	clots/watery/ foul smelling	clots/watery/ foul smelling

 
 
2. OBJECTIVE PARAMETER: The assessment will be done on the basis of the Appelbaum’s Uterine Scoring System for Reproduction ("USSR") by Trans Vaginal Sonography by color Doppler. It includes following parameters:

1. Endometrial Thickness (mm)
   
2. Endometrial layering
   
3. Myometrial Echogenicity
   
4. Uterine artery Doppler flow (PI)
   
5. Endometrial blood flow in zone 3
   
6. Myometrial blood flow (Gray scale)

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