Criteria for Selection

Inclusion Criteria

1. Married women with in the age group between 20-35 years.
2. Women with regular menstrual cycle.
3. Women with either primary or secondary infertility.
4. Women with history of recurrent abortion due to uterine factors (implantation defect).
5. Infertility due to only endometrial factors.

Exclusion Criteria

1. Married women of age below 20 yrs and above 35 yrs.
2. Severe pelvic inflammatory disease, pelvic organ prolapses, ovarian tumors, cancer of cervix and uterus.
3. Patients with systemic disorders like pulmonary Koch’s, Asthma, HTN, DM2, Thyroid dysfunction.
4. Other causes of female infertility like ovulatory dysfunction, tubal disease, cervical factors, pelvic endometriosis.

Investigations

• CBC, RBS
• T3, T4, TSH, FSH, LH
• Trans vaginal colour doppler sonography performed for diagnosis & assessment of result.

Assessment Parameters

According to Applebaum, certain sonographic qualities of the uterus are noted during the normal mid-cycle (day 10 - till ovulation). Table 1. These include:

• Endometrial thickness > 7 mm in greatest anterior-posterior (A-P) dimension (full thickness measured from the myometrial-endometrial junction to the endometrial-myometrial junction).
• Triple-layered ('5-line') endometrial appearance.
• Homogeneous myometrial echogenicity.
• Uterine artery blood flow < 3, as measured by pulsatility index (PI) on Doppler.
• Blood flow within zone 3 (hypoechoic inner layer) of the endometrium on colour Doppler.
• Myometrial blood flow - internal to the arcuate vessels (seen on Gray-scale)

Pitta is responsible for conversion of one Dhatu into another Dhatu in adequate amount by its Pakti^[7] (metabolic transformation) property, hence it is responsible for production of adequate level of hormonal support by aromatization of androgen into estrogen. Kapha by its Upachaya Guna (nutritive function) responsible for proliferative and secretory changes in endometrium for further development of cells, these three Dosha contributed in different stages of receptive endometrium formation by their normal function. Any vitiation in three Dosha is collectively responsible for defective endometrial formation. The drug assumed as effective for healthy endometrial formation was considered to have Tridoshaghna, Agnivardhaka, Balya, Rasayana, Brimhana properties. Phalakalyana Ghrita^[8] is - Tridoshaghana, Garbhasthapaka, Anulomna, Deepana and Rasayana properties. So, this formulation is selected for its evaluation as Yoni Pichu. Panchakola Phanta^[9]- Deepana Pachana and Vata Anulomana. Baladi Vati^[10] is Balya, Prajasthapaka, Brimhana, Vyasthapaka, Jeevaniya and Vrishya was selected for study.

Phalakalyana Ghrita and Baladi Vati both drug have phytoestrogenic^[11,12] property.

Yoni Pichu^[13]

Vaginal drug delivery possesses systemic as well as local action. The blood cells are abundant in vaginal wall. This vascularity of vaginal tissue is responsible for first uterine pass effect, or direct preferential vaginal to uterine transport. When drugs are absorbed in vagina, it passes to uterus by osmolarity of Sneha. The Sneha which remains in inner portion of vagina may show systemic effect by being absorbed and transported into inferior vena cava by vaginal, retro sigmoidal, vesical and uterine veins. Yoni Pichu Kriya is indicated in Vataja and Pittaja Yonivyapada Chikitsa.^[14,15] Vandhyatva due to Endometrial factor is Tridoshaja condition that’s why Yoni Pichu with Phalkalyana Ghrita was used in this clinical trial.

Follow-Up Study: Follow up study was conducted for two cycles (two consecutive months) after completion of the treatment.

Table 5: Effect of Therapy on Appelbaum’s Parameters

• Disturbed sleep pattern (25%) due to stress - Manasika Bhavas lead to Vata-Pitta Prakopa which resulted in vitiation of Dosha, Dhatu, Mala. Ultimately it hampers the proper formation of Rasa Dhatu and its
• History of hormonal pills intake (43.7%) with clomiphene citrate for augmentation of ovulation, had anti- estrogenic effect.

Discussion on effect of therapy

Endometrial Thickness:

The Brimhana property of therapy is directly responsible to increased thickness of endometrium. Phalakalyana Ghrita Yoni Pichu gives nourishment to endometrium potentially by its Brimhana property through local action. Baladi Vati help in follicular growth, proper formation of endometrium by activation of epidermal growth factor and phytoestrogenic properties.

Endometrial Layering:

Layering in endometrium seems due to differences in compactness of tissues in functional & basal layer. A distinct five lines indicate compact & favourable endometrium for implantation. As proliferative activities are Karma of Vata & secretory function of Kapha. The Ama Pachana & Vataanulomana & Brimhana action of drugs are substantiable.

Myometrial Echogenicity:

Homogenous myometrium indicates healthy myometrium of uterus. Proper cell division is the action of proper functioning of Vata, Yoni Pichu with Phalakalyana Ghrita does Snehana Karma and gives nourishment to local tissue while Baladi Vati by its Rasayana property rejuvenates tissues. Uniform contractility of myometrium is significant for normal of endometrial regeneration and implantation in the Kshetra - i.e., Garbhashaya. Thus, the Chala Guna of Vata is pacified and regulated by Sthiraguna of drugs in Yonipichu and strengthening of the tissues of myometrium through Snehana activity of Ghrita.

Uterine Artery Doppler Flow:

Uterine arteries are arterial supply to uterus with pulsatile index<2, while if abnormal resistance found in uterine artery, then pulsatile index is raised. Vata is responsible for any type of Gati (velocity); contraction and relaxation are also the action of Vata,