Infertility treatment

Recruiting

Conditions: Ovarian dysfunction, unspecified,

Registration Number: CTRI/2022/09/045921

Lead Sponsor: GovtNizamia Tibbi college and general hospital

Brief Summary: Ovulation is the central event in female reproduction.

Coordinated effects of hypothalamic gonadotropin releasing hormone, pituitary gonadotropins, ovarian estrogen and follicular response to these effects result in ovulation.

Any derangement of above factors results in ovarian dysfunction. The concept of ovulation has been mentioned in Unani encyclopedia by ancient Unani physiciansâ€™ centuries ago.

Ibaza is the term framed from Arabic dictionary for ovulation.

In classical Unani literature :

Literally, the word istiqrae means induction and ibaza means ovulation.

The description of adam ibaza (anovulation) has been mentioned under the heading of uqr.

Synonyms of Uqr:

-Uqm

-Banjhpan

-Adam hamal

-Butlan habal

-Usre habal

-Istiqrare hamal na hona

-Hamal na hona

INCIDENCE:-

Today nearly 30% to 40% of the infertile patients suffer from ovulatory dysfunction in which 75% of have polycystic ovaries and 20 to 25% of women with normal ovulation.

ETIO-PATHOGENESIS:-

An ovulation is a relatively common clinical disorder which may manifest as disordered cycle regularly or amenorrhea or in association with other symptoms such as hirsutism or galactorrhea.Disturbance at any level of HPO axis and feedback mechanism may inhibit the oocyte maturation and release, some of the abnormalities are amenable to treatment while some others like ovarian failure secondary to oocyte depletion are intractable.

Therefore it is useful to segregate the various causes of An ovulation into following compartments :

1.HYPOTHALAMIC:-

Hypogonadotrophic hypogonadism

Obesity

Kallmanâ€™s syndrome

Stress

Idiopathic

2.PITUITORY:-

Hyperprolactinaemia

Pituitory failure [hypogonadotrophic hypogonadism]

Sheehanâ€™s syndrome

Craniopharyngioma

Cerebral radiotheraphy

3.OVARIAN:-

Polycystic ovaries

premature ovarian failure

4.OTHERENDOCRINE:-

Hypothyroidism

Congenital adrenal hyperplasia

CLINICAL FEATURES

SIGN AND SYMPTOMS :-

patient may present with :

Asymptomatic

Menstrual irregularities like oligomenorrhoea (or) amenorrhea

Galactorrhoea

Infertility

Hyperandrogenism may present clinically as hirsutism,acne or male pattern alopecia

Obesity

g. Aging (older women)

h. Hyperprolactinemia

COMPLICATION:-

The serious consequences of chronic an ovulation are infertility and a greater risk for developing carcinoma of the endometrium.

UNANI CONCEPT:-

In classical Unani literature,various physicians mentioned the detailed description of female genital organs. Soranus and Ephesus[98-138 AD] Father of gynaecology,gave a detailed description about ovaries noting their shape,size and position.He believed that conception was most likely to take place directly after menstruation.He mentioned that ovaries were attatched to uterus and were not of firm consistency but glandular and covered with membrane.

Arastu and jalinoos mentioned that both male mani (sperm) and female mani (ovum) are responsible for conception. Jalinoos states that if both baiza (ovaries)of any animal are either excised or crushed or make it colder with shokran,then conception will not take place.

According to famous Unani physician buqrat, the cause of Anovulation is defect in mani(ovum)

Uqr is defined as when conception fails to occur or when there is a difficulty in conception either due to the defect in male or female partner.

Defect in female partner are attributed to the diseases of aazae mani (ovaries), rehm (uterus) or nafsani (psychological)

ASBAAB (ETIOLOGY)

Causes of uqr in female are broadly classified into following categories.

1. Defect in aazae mani (ovaries):

Decreased in the quantity of mani (ovum) i.e: oligo or anovulation.

Sue mizaj mukhtalif of mani (haar, barid or ratab)

Warm khusiyatur rehm (oophoritis)

2. Rehm (uterus):

Sue mizaj rehm (haar, barid, ratab or yabis)

Futoorat haiz (menstrual irreglaritiâ€¦

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Female

Target Recruitment: 40

Inclusion Criteria

MARRIED WOMEN PATIENTS WITH MENSTRUAL IRREGULARITIES PCOS PATIENTS WITH ANOVULATORY INFERTILITY.

Exclusion Criteria

AGE <18 AND >40 MALE AND CHILDREN UNMARRIED WOMEN PATIENT WITH SYSTEMIC DISEASES(CVA,CAD,COPD,D.M,HTN) PATIENT WITH CONGENITAL DEFECTS.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
GROUP A EACH PATIENT OUTCOME DEPENDS ON AFTER 3 CYCLES OF SUCESSFULL ORAL MEDICNE AND VAGINAL SUPPOSITORY of unani medicine (LOCAL MEDICINE) i.e90 days GROUP B OUT COME DEPENDS ON EACH PATIENT SUCESS FULL ORAL MEDICINE(CLOMIPHENE CITRATE) FOR 3 CYCLE ,With the help of ovulation study and Necessary hormonal assy test i.e for 90 days.which can be absorbed with the help of u/s whole Abdomen and pelvis before and during and after treatment	GROUP A EACH PATIENT OUTCOME DEPENDS ON AFTER 3 CYCLES OF SUCESSFULL ORAL MEDICNE i.e 90 days AND VAGINAL SUPPOSITORY(LOCAL MEDICINE) GROUP B OUT COME DEPENDS ON EACH PATIENT SUCESS FULL ORAL MEDICINE(CLOMIPHENE CITRATE) FOR 3 CYCLE i.e 90 days

Secondary Outcome Measures

Name	Time	Method
GROUP A EACH PATIENT OUTCOME DEPENDS ON AFTER 3 CYCLES OF SUCESSFULL ORAL MEDICNE AND VAGINAL SUPPOSITORY(LOCAL MEDICINE) i.e for 90 days GROUP B OUT COME DEPENDS ON EACH PATIENT SUCESS FULL ORAL MEDICINE(CLOMIPHENE CITRATE) FOR 3 CYCLE i.e 90 days. The out will be absorbed with the help of u/s whole Abdomen and pelvis before, during and after treatment	GROUP A EACH PATIENT OUTCOME DEPENDS ON AFTER 3 CYCLES OF SUCESSFULL ORAL MEDICNE AND VAGINAL SUPPOSITORY(LOCAL MEDICINE) GROUP B OUT COME DEPENDS ON EACH PATIENT SUCESS FULL ORAL MEDICINE(CLOMIPHENE CITRATE) FOR 3 CYCLE i.e 90 days

Trial Locations

Locations (1): GovtNizamia Tibbi college and General Hospital
🇮🇳
Hyderabad, TELANGANA, India
GovtNizamia Tibbi college and General Hospital
🇮🇳Hyderabad, TELANGANA, India
DrNida Firdous
Principal investigator
8247006617
dr.nida011@gmail.com