Role of testosterone supplementation in poor responders on IVF outcome

Active, not recruiting

• Conditions: Female infertility, unspecified, Patients undergoing Invitro fertilisation,

• Registration Number: CTRI/2017/10/010113
• Lead Sponsor: Besins Healthcare India Private Limited

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: ï‚· Tab Folic  acid  5mg OD ,ï‚· Tab Estradiol  Valerate  2mg TDS, ï‚· Tab Prednisolone  10 mg   BD  ,ï‚· Micronised Progesterone  Vaginal  Tablet  200mg  TDS, ï‚· 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-14
• Last Update Posted: 2020-04-28

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• 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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of oocytes retrieved per cycle	Number of oocytes retrieved per cycle

Secondary Outcome Measures

Name	Time	Method
To compare between 2 groups	1.Total dose and number of days of administration of Gonadotrophins ï‚· Cycle cancellation rate

Trial Locations

Locations (1)

All India Institute of Medical Sciences, New Delhi; 🇮🇳 South, DELHI, India

All India Institute of Medical Sciences, New Delhi

🇮🇳South, DELHI, India

Dr Neeta Singh

Principal investigator

9818506855

drneetasingh@yahoo.com