Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Intrauterine Insemination With Letrozole Versus Intrauterine Insemination in Natural Cycle. A Randomised Controlled Trial
Brief Summary: Rationale: Intrauterine insemination (IUI) is the treatment of first choice for couples with unexplained and mild male factor infertility in many countries, but it is controversial whether ovarian stimulation improves fertility outcomes. In recent retrospectively collected data, investigators found that in couples with unexplained and mild male factor infertility undergoing IUI, ovarian stimulation with letrozole increased live birth rate as compared to natural cycle IUI without substantially increasing the multiple pregnancy rate. Investigators therefore perform a randomized clinical trial (RCT) on the subject in the Centre of Reproductive Medicine, Peking University Third Hospital, Beijing, China.

Objective: To test the hypothesis that in couples with unexplained or mild male factor infertility scheduled for an IUI program ovarian stimulation with letrozole increases the live birth rate as compared to natural cycle treatment.

Study design Randomized clinical trial.

Study population Women diagnosed with unexplained or mild male factor infertility scheduled for treatment with IUI.

Intervention Women will be randomized for ovarian stimulation with letrozole or to natural cycle IUI. In the group allocated to ovarian stimulation, women will receive oral tablets letrozole 5 mg daily from cycle day 3-5 for 5 days. Investigators will treat the couples for 3 cycles, with a time horizon of 4 months.

Main study parameters/endpoints Primary outcome is ongoing pregnancy leading to live birth. Secondary endpoints are clinical pregnancy, multiple pregnancy, miscarriage rates, pregnancy complications and patients' costs.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness The strategies compared are already broadly applied in current practice. No additional risks are expected. There is no benefit for participants, but the results may benefit future subfertile couples.


Options:
A: Arm Label: arm 1:letrozole-pioglitazone -metformin group; Type: ACTIVE_COMPARATOR; Interventions: Drug: induction of ovulation using letrozole-pioglitazone-metformin, Radiation: transvaginal ultrasound, Other: body mass index (BMI) calculation, Other: day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone, Other: pretreatment blood urea and serum creatinine, Other: serum estradiol (E2) on day 12, Other: serum progesterone on day 21, Other: blood urea and serum creatinine every month | Arm Label: arm 2: clomiphene citrate-pioglitazone-metformin; Type: ACTIVE_COMPARATOR; Interventions: Drug: induction of ovulation using clomiphene citrate-pioglitazone-metformin, Radiation: transvaginal ultrasound, Other: body mass index (BMI) calculation, Other: day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone, Other: pretreatment blood urea and serum creatinine, Other: serum estradiol (E2) on day 12, Other: serum progesterone on day 21, Other: blood urea and serum creatinine every month | Intervention Type: DRUG; Name: induction of ovulation using letrozole-pioglitazone-metformin; Assigned to Arm(s): arm 1:letrozole-pioglitazone -metformin group | Intervention Type: DRUG; Name: induction of ovulation using clomiphene citrate-pioglitazone-metformin; Assigned to Arm(s): arm 2: clomiphene citrate-pioglitazone-metformin | Intervention Type: RADIATION; Name: transvaginal ultrasound; Assigned to Arm(s): arm 1:letrozole-pioglitazone -metformin group, arm 2: clomiphene citrate-pioglitazone-metformin | Intervention Type: OTHER; Name: body mass index (BMI) calculation; Assigned to Arm(s): arm 1:letrozole-pioglitazone -metformin group, arm 2: clomiphene citrate-pioglitazone-metformin | Intervention Type: OTHER; Name: day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone; Assigned to Arm(s): arm 1:letrozole-pioglitazone -metformin group, arm 2: clomiphene citrate-pioglitazone-metformin | Intervention Type: OTHER; Name: pretreatment blood urea and serum creatinine; Assigned to Arm(s): arm 1:letrozole-pioglitazone -metformin group, arm 2: clomiphene citrate-pioglitazone-metformin | Intervention Type: OTHER; Name: serum estradiol (E2) on day 12; Assigned to Arm(s): arm 1:letrozole-pioglitazone -metformin group, arm 2: clomiphene citrate-pioglitazone-metformin | Intervention Type: OTHER; Name: serum progesterone on day 21; Assigned to Arm(s): arm 1:letrozole-pioglitazone -metformin group, arm 2: clomiphene citrate-pioglitazone-metformin | Intervention Type: OTHER; Name: blood urea and serum creatinine every month; Assigned to Arm(s): arm 1:letrozole-pioglitazone -metformin group, arm 2: clomiphene citrate-pioglitazone-metformin
B: Arm Label: letrozole group; Type: EXPERIMENTAL; Interventions: Drug: letrozole | Arm Label: natural cycle group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: letrozole; Assigned to Arm(s): letrozole group
C: Arm Label: Personalized acupuncture; Type: EXPERIMENTAL; Interventions: Other: Acupuncture | Arm Label: Fixed acupuncture; Type: EXPERIMENTAL; Interventions: Other: Acupuncture | Arm Label: Letrozole; Type: ACTIVE_COMPARATOR; Interventions: Drug: Letrozole | Arm Label: Placebo letrozole; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo letrozole | Intervention Type: OTHER; Name: Acupuncture; Assigned to Arm(s): Fixed acupuncture, Personalized acupuncture | Intervention Type: DRUG; Name: Letrozole; Assigned to Arm(s): Letrozole | Intervention Type: DRUG; Name: Placebo letrozole; Assigned to Arm(s): Placebo letrozole
D: Arm Label: Graceful Lifestyle Changes & MYO; Type: EXPERIMENTAL; Interventions: Behavioral: Graceful Lifestyle Changes, Dietary Supplement: Myo-inositol | Arm Label: Graceful Lifestyle Changes; Type: EXPERIMENTAL; Interventions: Behavioral: Graceful Lifestyle Changes | Arm Label: Letrozole & MYO; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: Myo-inositol, Drug: Letrozole | Arm Label: Letrozole; Type: PLACEBO_COMPARATOR; Interventions: Drug: Letrozole | Intervention Type: BEHAVIORAL; Name: Graceful Lifestyle Changes; Assigned to Arm(s): Graceful Lifestyle Changes, Graceful Lifestyle Changes & MYO | Intervention Type: DIETARY_SUPPLEMENT; Name: Myo-inositol; Assigned to Arm(s): Graceful Lifestyle Changes & MYO, Letrozole & MYO | Intervention Type: DRUG; Name: Letrozole; Assigned to Arm(s): Letrozole, Letrozole & MYO

Answer: B