Clinical trial NCT04602143: Effect of Testosterone Pretreatment in POR
Official title: Therapeutic Effect of Prolonged Testosterone Pretreatment in Women With Poor Ovarian Response: a Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Hanoi Medical University
Sponsor class: OTHER
Collaborators: name: National Hospital of Obstetrics and Gynecology
First posted: 2020-10-26
Enrollment: 165
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 47
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria: patients who met at least two of the following criteria

* Having one previous IVF/ intracytoplasmic sperm injection (ICSI) cycle with ≤ 3 oocytes recruited.
* AFC ≤ 5 - 7.
* Anti-Mullerian hormone (AMH) ≤ 0.5 - 1.1 ng/mL.

Exclusion Criteria:

* donated gamete IVF cycles
* Thyroid disease
* Liver and kidney dysfunction
* Abnormal genitalia

Primary outcomes:
measure: Number of oocytes retrieved
timeFrame: 30 minutes after oocyte retrieval complete
Secondary outcomes:
measure: Pregnancy rates.
timeFrame: 14 days after embryo transfer
measure: clinical pregnancy rates.
timeFrame: 4 weeks after embryo transfer
measure: Ongoing pregnancy rates
timeFrame: after 12 weeks of gestation
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Hanoi Medical University, Vietnam
Study officials:
affiliation: Hanoi Medical University
name: Hung S Ho, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hanoi Medical University
name: Tien V Nguyen, MD, PhD
role: STUDY_CHAIR
References: