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Clinical Trial Details (PDF Generation Date :- Sat, 16 Sep 2023 01:10:51 GMT) CTRI Number CTRI/2014/05/004631 [Registered on: 28/05/2014] - Trial Registered Prospectively Last Modified On 12/10/2021 Post Graduate Thesis No Type of Trial Type of Study Study Design Observational Case Control Study Non-randomized, Multiple Arm Trial Public Title of Study To study vitamin D and AMH hormone deficiency and its effect on fertility Scientific Title of Study To study the Vitamin D levels in infertile females and to evaluate the correlation of vitamin D deficiency with antimullerian hormone levels in infertile females as compared to fertile females.
Secondary IDs if Any Secondary ID Details of Principal Investigator or overall Trial Coordinator (multi-center study) Details Contact Person (Scientific Query) Details Contact Person (Public Query) NIL Name Designation Affiliation Address Phone Fax Email Name Designation Affiliation Address Phone Fax Email Name Designation Affiliation Identifier NIL Details of Principal Investigator Dr Indu Lata Assistant Professor,Maternal and Reproductive Health SANJAY GANDHI POSTGRADAUTE INSTITUTE OF MEDICAL SCIENCES,LUCKNOW,UP,INDIA Assistant Professor,Maternal and Reproductive Health, Sanjay Gandhi Postgradaute Institute of Medical Sciences,Lucknow,UP,India ASSISTANT PROFESSOR,DEPT OF ANESTHESIOLOGY SANJAY GANDHI POSTGRADAUTE INSTITUTE OF MEDICAL SCIENCES,LUCKNOW,UP,INDIA Lucknow UTTAR PRADESH 226014 India 918004904523 drindusandeep@gmail.com Details Contact Person (Scientific Query) Dr Indu Lata Assistant Professor,Maternal and Reproductive Health SANJAY GANDHI POSTGRADAUTE INSTITUTE OF MEDICAL SCIENCES,LUCKNOW,UP,INDIA Assistant Professor,Maternal and Reproductive Health, Sanjay Gandhi Postgradaute Institute of Medical Sciences,Lucknow,UP,India ASSISTANT PROFESSOR,DEPT OF ANESTHESIOLOGY SANJAY GANDHI POSTGRADAUTE INSTITUTE OF MEDICAL SCIENCES,LUCKNOW,UP,INDIA Lucknow UTTAR PRADESH 226014 India 918004904523 drindusandeep@gmail.com Details Contact Person (Public Query) Dr Indu Lata Assistant Professor,Maternal and Reproductive Health SANJAY GANDHI POSTGRADAUTE INSTITUTE OF MEDICAL page 1 / 6 PDF of TrialCTRI Website URL - http://ctri.nic.in Address Phone Fax Email > SGPGIMS Name Address SCIENCES,LUCKNOW,UP,INDIA Assistant Professor,Maternal and Reproductive Health, Sanjay Gandhi Postgradaute Institute of Medical Sciences,Lucknow,UP,India ASSISTANT PROFESSOR,DEPT OF ANESTHESIOLOGY SANJAY GANDHI POSTGRADAUTE INSTITUTE OF MEDICAL SCIENCES,LUCKNOW,UP,INDIA Lucknow UTTAR PRADESH 226014 India 918004904523 drindusandeep@gmail.com Source of Monetary or Material Support Primary Sponsor Details SGPGIMS SANJAY GANDHI POSTGRADUATE INSTITUTE OF MEDICAL SCIENCES,LUCKNOW,UP,INDIA Source of Monetary or Material Support Primary Sponsor Type of Sponsor Research institution and hospital Details of Secondary Sponsor Name NIL Countries of Recruitment Sites of Study List of Countries India Name of Principal Investigator Address NIL Name of Site Site Address Phone/Fax/Email DR INDU LATA SGPGIMS 8004904523 0522-2660817 drindusandeep@gmail.
com Department of Maternal and Reproductive Health,PMSSY Block,S GPGIMS,LUCKNOW,U P,INDIA Lucknow UTTAR PRADESH Details of Ethics Committee Name of Committee Approval Status Date of Approval Is Independent Ethics Committee?
IEC,SGPGIMS Approved 12/03/2014 Yes Regulatory Clearance Status from DCGI Health Condition / Problems Studied Status Not Applicable Health Type Patients Healthy Human Volunteers Intervention / Comparator Agent Inclusion Criteria Patients Type Age From Age To Date No Date Specified Condition Abnormal product of conception, unspecified AS CONTROL COMING FOR ROUTINE CHECK UP OR DUE TO OTHER PROBLEMS BESIDE INFERTILITY INFERTILE FEMALES COMING FOR REFERRAL,DIAGNOSIS AND MANAGEMENT Name Details Inclusion Criteria 18.00 Year(s) 40.00 Year(s) page 2 / 6 PDF of TrialCTRI Website URL - http://ctri.nic.in Gender Details Details Exclusion Criteria Female healthy females of age group between 18-40 years with history of infertility (inability to conceive even after one year of unprotected intercourse) for cases and healthy fertile non-pregnant females between same age group for control who is having at least one successful Pregnancy.
Exclusion Criteria History of Smoking(tobacco use),Oral Contraceptive Pill use, any hormonal or steroid drug use, known Vitamin D deficiency, obesity (BMI>35),Endometriosis, Thyroid disorders , and Polycystic ovarian syndrome.
Method of Generating Random Sequence Not Applicable Method of Concealment Not Applicable Blinding/Masking Not Applicable Primary Outcome Outcome vitamin D defiency is a known risk factors even in tropical countries and in Indian womens.Recent studies had proved role of Vitamin D in female reproductive system and fertility.AMH is also a highy specific and senstive predictive marker of ovarian reserve .Preliminary humen and animal studies showing promising results in relation of vitramin D with AMH.Results of present study may shows imporatnt correlation between Vitamin D and AMH levels that may be useful in management of infertlity.
Timepoints two years from start of study Secondary Outcome Outcome Target Sample Size Results of present study may shows imporatnt correlation between Vitamin D and AMH levels that may be useful in management of infertlity.
Total Sample Size=70 Sample Size from India=70 Final Enrollment numbers achieved (Total)=70 Final Enrollment numbers achieved (India)=70 Phase of Trial N/A Timepoints two years from start of study Date of First Enrollment (India) Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial (India) Publication Details Brief Summary 15/06/2014 No Date Specified Years=2 Months=2 Days=30 Not Applicable Completed Lata I, Tiwari S, Gupta A, Yadav S, Yadav S. To study the vitamin D levels in infertile females and correlation of Vitamin D deficiency with AMH levels in comparison to fertile females.
J Hum Reprod Sci 2017;10:86-90 Title: To study the Vitamin D deficiency in infertile females and to evaluate the correlation of vitamin D deficiency with antimullerian hormone levels in infertile females compare to fertile females.

page 3 / 6 PDF of TrialCTRI Website URL - http://ctri.nic.in Introduction: As serum AMH levels essentially reflect the ovarian follicular pool, reduction in the number of small growing follicles may be followed by a reduction in circulating AMH.
Recently, AMH has been evaluated by several groups as a potential novel clinical marker of ovarian reserve and of response to gonadotrophins (Tremellen et al., 2005;Fiçicioglu et al., 2006; La Marca et al., 2007).In women, anti-Müllerian hormone (AMH) levels may represent the ovarian follicular pool and could be a useful marker of ovarian reserve.

[3]Vitamin D has a variety of physiological roles, including regulating calcium uptake, inhibiting cell proliferation, and stimulating cell differentiation [4].
This hormone primarily exerts its effects through the vitamin D receptor (VDR), a member of the steroid-thyroid-retinoid receptor family of ligand-activated transcription factors.

Through its receptor, vitamin D can modify gene transcription, as well as protein and mRNA production.

In rats, dietary vitamin D deficiency leads to a 25% reduction in overall fertility.
[5] AMH emerged as a target gene regulated by vitamin D (1, 25-dihydroxyvitamin D3) from cDNA microarray analysis of a prostate cancer cell line.

Krishnan et al.

found that AMH mRNA expression is up-regulated in response to vitamin D in vitro, and these investigators subsequently identified a functional vitamin D-response element (VDRE) in the human AMH promoter, demonstrating a direct effect of vitamin D on AMH expression.
It had been studied Vitamin D RNA is expressed in the granulosa cells of the hen ovary.

Additionally, this had been shown that vitamin D functions to regulate AMH and FSHR mRNA, and thereby is likely involved in the follicle-selection process.

[6] Aim and Objectives: 1.

To study the incidence of Vitamin D deficiency in infertile females 2.

To study the correlation of Vitamin D deifiency with antimullerian hormone (AMH) levels in infertile females 3.
To study the correlation of Vitamin D deifiency with antimullerian hormone (AMH) levels in fertilite females 4.

To compare the results of Vitamin D deifiency with antimullerian hormone (AMH) levels of infertile females with fertile females Material and Method: This prospective observational study would be done after taking informed written consent on female patients attending OPD at our institute for infertility management.
All the patients enrolled in study will be taken detailed history; systemic examination (BMI) and gynaecological examination will be done.

They will be investigated with baseline blood investigation and investigation for infertility workup will be done as per protocols and guidelines of infertility management.

After all above workup all qualified women’s with infertility will be enrolled in this study.
With full aseptic precaution 10 ml of blood sample will be taken for battery of tests for infertility workup.

Besides this Vitamin D and AMH level will be done by kit method at the laboratory of the Institute.

The patient will be followed till the investigation report validated and counseled as per the results of test.

Further page 4 / 6 PDF of TrialCTRI Website URL - http://ctri.nic.in treatment will be offered as per test results and standard infertility treatment guidelines.
Besides this to compare infertile females we will also enroll fertile females coming to hospital for various reasons to take health advice after informed written consent as control.

They will also be investigated with vitamin D levels and who have low vitamin D level will be further investigated for AMH levels.

After this we will compare both groups with vitamin D deficiency and their correlation with AMH to know statistically significance and correlations by using two sided two sample t-test.
Power of study calculation: for sample size (sheet attached separately) 1.

For calculating incidence of vitamin D deficiency in infertile females P=90%, SD=9%, P=0.05, CD=5, N=70 If we calculate the sample size based on vitamin D, SD =9, CD (Clinical significance difference) was considered=5.the level of significance (P=0.05) and power of the test=90%, then sample size will be 70.

2.
2.

Difference in AMH levels in Infertile and fertile females: Assumption power 90% and p=0.05, mean AMH level in infertile 1.0+-0.6 and in fertile 3.0+-0.6, a group sample size of 31 in each group to achieve 90% power to detect a difference between the null hypothesis that both group means with a significance level (alpha) of 0.05000 using two sided two-sample t-test, to prevent drop out we will take 35 cases in each group.
So as per above calculation following number of patients will be enrolled in study: Patient* N = 70 (to see incidence of vitamin D deficiency in infertile females) N1= 35 (infertile females with vitamin D deficiency for AMH levels) Control* N2= 35 (fertile females with vitamin D deficiency for AMH levels) Duration of study: two years Duration of subject participation: (no.
of visit by a participant in study): two month (2 visits) Inclusion criteria’s: healthy females of age group between 18-40 years with history of infertility (inability to conceive even after one year of unprotected intercourse) for cases and healthy fertile non-pregnant females between same age group for control who is having at least one successful Pregnancy.

Risk and the benefits: there is no apparent risk to patients due to enrollment in this study.
There may fare numbers of benefit to infertile women’s if they were taken in this study as their Vitamin D level will be known that affect almost all system and wellbeing of routine daily life.

There will be interrogation of ovarian reserve of patient by AMH level, overall status of both investigations and its correlation will further guide in infertility management of patients.
Outcome:After matching inclusion and exclusion criteria out of total 70 infertile females, 45 page 5 / 6 PDF of TrialCTRI Website URL - http://ctri.nic.in were found to have VDD.

Of these 35 patients were identified as cases; in whom, the AMH levels were assessed.

As control 35 fertile normal females were taken, in which vitamin D and AMH were taken.

In both groups, correlation of VDD with AMH was studied.

The VDD was present in 64.28% of infertile females.
In vitamin D deficient cases, the mean for vitamin D was 6.18 ± 2.09 and AMH was 1.94 ± 1.30.

In vitamin D deficient controls, the mean for vitamin D was 4.85 ± 3.02 and AMH was 3.47 ± 2.59.

On comparison, the vitamin D levels were lower in fertile than infertile females, which was significant (P = 0.04), and AMH levels were lower in cases than control group (P = 0.003).The VDD was present in 64.28% of infertile females.
No significant correlation was found in between VDD and AMH levels in both the groups.

Completed study Powered by TCPDF (www.tcpdf.org) page 6 / 6 PDF of TrialCTRI Website URL - http://ctri.nic.in