Effect of Testosterone Pretreatment in POR

Infertility Clinical Trial

Official title:

Therapeutic Effect of Prolonged Testosterone Pretreatment in Women With Poor Ovarian Response: a Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04602143
• Other study ID #: hoangquochuy, MD
• Status: Completed
• Phase: N/A
• Start date: February 16, 2018
• Est. completion date: June 30, 2020

Study information

• Verified date: October 2020
• Source: Hanoi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 165
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 47 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• Testosterone gel
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.

Locations

Country	Name	City	State
Vietnam	Hanoi Medical University, Vietnam	Hanoi

Sponsors (2)

Lead Sponsor	Collaborator
Hanoi Medical University	National Hospital of Obstetrics and Gynecology

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of oocytes retrieved	The main outcomes of our study were the total number of retrieved	30 minutes after oocyte retrieval complete
Secondary	Pregnancy rates.	Pregnancy was defined as positive when the serum beta-hCG level was = 50 IU/L	14 days after embryo transfer
Secondary	clinical pregnancy rates.	Clinical pregnancy was defined as the presence of a gestational sac identified by transvaginal ultrasound	4 weeks after embryo transfer
Secondary	Ongoing pregnancy rates	Ongoing pregnancy was defined as a viable intrauterine pregnancy after 12 weeks of gestation.	after 12 weeks of gestation