| CTRI Number |
CTRI/2017/10/010113 [Registered on: 16/10/2017] Trial Registered Retrospectively |
| Last Modified On: |
28/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Role of testosterone supplementation in poor responders on IVF outcome |
|
Scientific Title of Study
|
Role of transdermal Testosterone gel pretreatment in poor responders on IVF outcome- A prospective randomised controlled trial with active control |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Neeta Singh |
| Designation |
Professor, Obstetrics and Gynecology |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Obstetrics and Gynecology,
All India Institute of Medical Sciences,
Ansari Nagar,
New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
drneetasingh@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Padmashri P |
| Designation |
Junior Resident (Academic), Obstetrics and Gynecology |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Obstetrics and Gynecology,
All India Institute of Medical Sciences,
Ansari Nagar,
New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
ppadmashri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neeta Singh |
| Designation |
Professor, Obstetrics and Gynecology |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Obstetrics and Gynecology,
All India Institute of Medical Sciences,
Ansari Nagar,
New Delhi
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
drneetasingh@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Besins Healthcare India Private Limited,
Alpha, Main St, Hiranandani Gardens, Sainath Nagar, Powai, Mumbai, Maharashtra 400076 |
|
|
Primary Sponsor
|
| Name |
Besins Healthcare India Private Limited |
| Address |
Alpha 403, 4th floor, Powai Main Street, Powai, Mumbai - 400076, Hiranandani Gardens |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Neeta Singh |
All India Institute of Medical Sciences, New Delhi |
Assisted Reproductive Technology Centre, Department of Obstetrics and Gynaecology,
All India Institute of Medical Sciences,
Ansari Nagar
South
DELHI |
9818506855
drneetasingh@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee for postgraduate research,AIIMS,New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N979||Female infertility, unspecified, Patients undergoing Invitro fertilisation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Control arm will not receive gel but will receive standard treatment without the gel |
| Intervention |
Transdermal Testosterone gel (Androgel from Besins Health care India Pvt Ltd.) |
Transdermal Testosterone gel (Androgel from Besins Health care India Pvt Ltd.) 12.5 mg per day pretreatment in the month before stimulation for around 21-25 days depending on the duration of menstrual cycle of the woman till day 1 of menstruation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
39.00 Year(s) |
| Gender |
Female |
| Details |
Patients from whom < or equal to 5 oocytes were retrieved at hCG trigger in previous failed IVF/ICSI cycle with:
1.FSH < or equal to 10
2.Normal TSH, Prolactin, hepatic and renal function
3.Normal uterine cavity as assessed by Hysteroscopy and 3D USG
4.None having taken any fertility medication like gonadotropins or clomiphene in the past 3 months.
5.Patients willing to participate in the trial |
|
| ExclusionCriteria |
| Details |
1.Women with known causes of decreased ovarian reserve like endometriosis grade 3 or higher
2.Women with pre-existing comorbidities like uncontrolled Diabetes, Hypertension and other chronic diseases like Chronic liver or kidney disease
3.Women with known autoimmune disorders like SLE, Autoimmune hemolytic anemia
4.Abnormal parental karyotype Abnormal Uterine cavity such as thin endometrium, severe Adenomyosis
5.Women not willing to participate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
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Primary Outcome
|
| Outcome |
TimePoints |
| Number of oocytes retrieved per cycle |
Number of oocytes retrieved per cycle |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare between 2 groups
1.Total dose and number of days of administration of Gonadotrophins ï‚· Cycle cancellation rate
2.Fertilization rate
3.Cleavage rate
4.Number of good quality embryos
5.Biochemical pregnancy
6.Implantation rate
7.Clinical pregnancy rate
8.Ongoing pregnancy Rate
9.Pregnancy wastage or nonviable pregnancy |
To compare between 2 groups
1.Total dose and number of days of administration of Gonadotrophins ï‚· Cycle cancellation rate
2.Fertilization rate
3.Cleavage rate
4.Number of good quality embryos
5.Biochemical pregnancy
6.Implantation rate
7.Clinical pregnancy rate
8.Ongoing pregnancy Rate
9.Pregnancy wastage or nonviable pregnancy |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
14/08/2017 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
METHODOLOGY: The subjects will be randomized into two groups and will receive the treatment according to the protocol. Group I: This group will receive Transsdermal Testosterone gel (Androgel from Besins Health care India Pvt Ltd.) Group II: This group will receive standard treatment Both the groups will receive Estrogen-Progesterone pretreatment before stimulation. On enrollment, a detailed clinical history including menstrual history, obstetric history including history of pregnancy losses, history of prior treatment taken for infertility, details of previous IVF cycles will be taken. Detailed examination including general physical examination and gynaecological examination will be done. Systemic examination including secondary sexual characteristics, thyroid and breast examination will be done. A detailed per vaginal bimanual examination will be done to rule out any local pelvic pathology. Baseline blood testing will be done for complete blood count, blood glucose, liver function tests and kidney function tests.A detailed and meticulous infertility work up will be done . Combination of Estradiol valerate 1mg/day and T.Norethindrone 5 mg/day will be given for 21 days in the cycle preceding stimulation. Testosterone pretreatment group will be given Androgel 12.5mg starting from 6th day of estrogen-Progesterone treatment for 21 days where as control group will not receive testosterone pretreatment. Patients will be asked to apply the prescribed gel in B/L upper arms in the morning cleaned and dried previously. The gel will have to be applied in thin layer. Testosterone gel will be continued until the first day of menstruation and from the second day, ovarian stimulation will be started. Flexible GnRH antagonist protocol will be followed in all patients. rhFSH (recombinant human FSH) will be given at required doses starting from 300 IU and dose would be adjusted based on respone. HMG would be added accordingly. When leading follicle is >13-14mm diameter, Cetrorelix 0.25mg/day will be started and continued till the day of trigger. rHCG injection(250 mg SC) will be given after >1 follicle is >18mm to trigger follicular maturation. In both the groups, transvaginal ultrasound–guided oocyte retrieval will be performed 36 hours after HCG injection, and after IVF or ICSI, embryo transfer will be done in the uterus on the third day after oocyte retrieval. It will be then followed by certain medications:  Tab Folic acid 5mg OD , Tab Estradiol Valerate 2mg TDS,  Tab Prednisolone 10 mg BD , Micronised Progesterone Vaginal Tablet 200mg TDS,  Tab. Ecospirin 75mg OD After 16 days of embryo transfer, UPT and beta HCG will be done. Once patient tests positive for UPT, these drugs are continued till fetal cardiac activity is positive after which T.Estradiol Valerate and T.Prednisolone are tapered in the range of T.Estradiol Valerate twice daily for 1 week followed by once daily for 1 week and Tab. Prednisolone 5mg once daily for 1 week and then stop. |