Management of Female Infertility - Endometrium Factor

Phase 1/2

Completed

• Conditions: Female infertility of uterine origin,

• Registration Number: CTRI/2020/02/023425
• Lead Sponsor: Institute for Post Graduate Teaching And Research in Ayurveda Gujarat Ayurved University

Brief Summary

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): *SaubhagyanandanaGhrita Yonipeechu* and *Jeevaniya Churna*orally is not effective in the management of *Vandhyatva* (femaleinfertility) w.s.r to endometrium thickness?

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

Plan of study:  (1)                Review of Literature (2)                Pharmacognostical study (3)                Pharmaceutical study (4)                Clinical study Clinical study DIAGNOSTIC CRITERIA: Female patients having endometrial thickness Â£ 7 mm on TVS findings (up to 14th day of menstrual cycle) will be included for the study. INCLUSION CRITERIA: 1.      Females of child bearing age of 20 to 40 years. 2.      Female having active marital life of 1 year. 3.      Female patients having primary and secondary both type of infertility with endometrial thickness£ 7 mm diagnosed by TVS, irrespective of its cause. EXCLUSION CRITERIA: 1.      Female patients having age less than 20 years and more than 40 years. 2.      Female patients having infertility due to bilateral tubal blockage. 3.      Carcinoma of reproductive tract. 4.      Active inflammatory disease, eg. -Acute PID, STD like HIV, VDRL, HBsAG, HCV. 5.      Congenital anomaly of reproductive tract. 6.      Uncontrolled systemic disease like Diabetes, Hypertension. Investigations: 1. General investigations          Hematological Examination- Hb% , T.L.C., D.L.C., E.S.R.,PCV [BT,AT]          Biochemical Examination: FBS. [BT,AT]          Urine Examination: Routine and Microscopic examination. [BT,AT]          Serological Examination- HIV, HBsAg, VDRL, HCV[BT]          Pregnancy test – if required. 2.   Special Investigation: Transvaginal Ultrasonography (B.T,  A.T.) - To see the Appel Baums Uterine Scoring Pattern. 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)

---

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-21
• Study Completion: 2021-03-04
• Last Update Posted: 2021-06-26

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• Female having active marital life of 1 year.
• Female patients having primary and secondary both type of infertility with endometrial thickness of 7 mm diagnosed by TVS, irrespective of its cause.
• Female patients indicated for Yogabasti and Uttarabasti.

Exclusion Criteria

• 1.Female patients having age less than 20 years and more than 40 years.
• 2.Female patients having infertility due to bilateral tubal blockage.
• 3.Carcinoma of reproductive tract.
• 4.Active inflammatory disease, eg.
• Acute PID, STD like HIV, VDRL, HBsAG, HCV.
• 5.Congenital anomaly of reproductive tract.
• 6.Uncontrolled systemic disease like Diabetes, Hypertension.
• 7.Female patients contraindicatedfor Yogabasti and Uttarabasti.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate effect of Yonipeechu and oral drug in the management of Vandhyatva (female infertility) w.s.r.to endometrium thickness.	30 days

Secondary Outcome Measures

Name	Time	Method
To evaluate efficacy of Yonipeechu and oral drug in the associate complains of menstrual abnormalities, like oligomenorrhoea, dysmenorrhoea, etc.	30 days

Trial Locations

Locations (1)

Institute for Post Graduate Teaching & Research in Ayurveda Gujarat Ayurved University; 🇮🇳 Jamnagar, GUJARAT, India

Institute for Post Graduate Teaching & Research in Ayurveda Gujarat Ayurved University

🇮🇳Jamnagar, GUJARAT, India

Jalpa D Rupareliya

Principal investigator

9765396906

jalparupareliya20@gmail.com