Effect of Testosterone Pretreatment in POR
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      This study compared the therapeutic effect of 4- and 6-week TTG application before controlled
      ovarian hyperstimulation (COH) in POR.
    

Detailed description: 
      This randomized control trial (RCT) was conducted between January 2018 and September 2019 at
      the National Center for Reproductive Medicine, Hanoi, Vietnam. The eligibility of a total of
      165 women with POR, undergoing IVF treatment, to be enrolled in the study was assessed.
      Inclusion criteria included patients who met at least two of the following criteria: (i)
      having one previous IVF/ intracytoplasmic sperm injection (ICSI) cycle with ≤ 3 oocytes
      recruited; (ii) AFC ≤ 5-7; and (iii) anti-Mullerian hormone (AMH) ≤ 0.5 - 1.1 ng/mL were
      enrolled. Exclusion criteria included donated gamete IVF cycles, thyroid disease, liver and
      kidney dysfunction, and abnormal genitalia. After screening, eligible patients were randomly
      allocated into two TTG intervention groups (4-week and 6-week groups) and one control group
      through a manual lottery. Allocation concealment was by sequentially numbered, opaque, sealed
      envelopes. All participants were blinded to group assignment, but researchers were not
      blinded.

      Serum testosterone are measured before treatment. Durations of androgen supplement are 4 or
      6-weeks. After completing the pretreatment, patients are asked to come back when they have
      menses to begin IVF treatment. Serum testosterone is measured again after the pretreatment in
      both groups. Patients will be interviewed for side effects and compliance of treatment.

      After treatment, patients in both group undergo IVF treatment. IVF treatment will then be
      performed for all patients, according to the current hospital treatment protocols.

      Patients will be followed up at least until 12th week of gestation, if they have positive
      pregnancy test after embryo transfer.

      Data were analyzed using STATA software version 14.0 (Stata Corporation, College Station, TX,
      USA). Data were analyzed on an intention-to-treat basis. Proportions, means, and standard
      deviations (SDs) were examined and presented for selected baseline variables by treatment
      group. Comparisons of baseline characteristics and outcomes by treatment group were performed
      with the use of ANOVA for continuous variables and a chi-square test for proportions. A
      Bonferroni correction was used for multiple testing, in which the resulting P-value was
      multiplied by the number of tests that measured similar constructs. Multivariable logistic
      regressions were used to quantify the effects of the treatment group, adjusted for all
      potential confounders including maternal age, body mass index (BMI), infertility duration,
      primary or secondary infertility, and history of IVF treatment. All statistical tests were
      two-sided, and P values < 0.05 were considered statistically significant.
    

Intervention name(s): Testosterone gel
Intervention type(s): Drug
Intervention description(s): Apply 12.5mg testosterone gel to the abdomen and rub on with one finger, once a day, in the morning, then allow sites to dry and cover with clothing. Continue the treatment for 4 or 6 weeks until next IVF treatment.
Other intervention name(s): Androgel 1% Transdermal Gel
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment