Clinical trial NCT02571543: Can Ibuprofen Delay Ovulation in Natural Cycle-IVF?
Official title: Investigation of Ibuprofen in the Delay of Ovulation in NC-IVF (Natural Cycle in Vitro Fertilisation) Therapy With the Objective of Reducing Premature Ovulation and Thus Improving Effectivity (Off Label Use)
Conditions: Ovulation
Ovulation Inhibition
Ovulation Inhibition/Drug Effects
Pregnancy
Fertilization in Vitro/Methods
Summary: During natural cycle in vitro fertilisation, no gonadotropin stimulation is used to stimulate oocyte production. Ovulation is induced with HCG (human chorionic gonadotropin) and the follicle is retrieved 36 hours later.
In this study the patient in the intervention group will receive Ibuprofen as a study intervention beginning at the same time as the HCG injection. The treatment dose will either be 400mg every 8 to 12 hours or 800mg every 8 to 12 hours until the follicle retrieval, totalling 5 tablets. Instead of the usual time period of 36 hours, the follicular punction will occur after 42 hours. Should the oocyte still be accessible after this time period, then it is proven that Ibuprofen delays ovulation. In this case the patient will continue the regular NC-IVF treatment cycle.
The study design is a admissible two-stage design. During stage 1, 8 cycles in 8 patients will be examined. Should it be the case that after these 8 patients have completed a cycle, 4 or more show a positive treatment effect from the Ibuprofen intake, then the study will continue to stage 2 with 17 more more patients, totalling 25.
Should it be the case however, that after 8 patients, 3 or less show an effect of the Ibuprofen intake, then the study will be stopped prematurely for futility. The study intervention will be increased to 800mg of Ibuprofen and the study will recommence with 8 more patients.
A control group will consist of women undergoing intrauterine insemination (IUI) or timed sexual intercourse (TSI). 42 hours after Beta-HCG injection, an ultrasound examination will be performed in order to determine the number of remaining follicles in the ovary. This examination is to verify and control the proposed time limit of 42 hours.
Interventions:
description: Beginning with 400mg Ibuprofen, 5 times. Depending on the outcome of stage 1 the treatment dose will increase to 800mg, 5 times.
name: Ibuprofen
other_name: Brufen®
type: Drug
Study arms:
design_group_description: 2 Stage study design. Stage 1: 8 patients will be treated with the lower dose of 400mg of Ibuprofen. Should the efficacy be insufficient (3 or less patients) then the study will stop and stage 1 will recommence with 800mg.<br/>Stage 2: 17 patients will be treated either with the lower dose of 400mg or the higher dose of 800mg of Ibuprofen should the respective stage 1 have been successful (4 or more patients showing an effect).
design_group_title: Intervention
design_group_type: Experimental
design_group_description: The control group will consist of a no-treatment group of patients undergoing Intrauterine Insemination (IUI) or Timed Sexual intercourse (TSI), to verify the delay between LH-Peak onset and ovulation. 42h after Beta-HCG injection inducing LH-Peak, ovulation will be determined by ultrasound examination.
design_group_title: Control
design_group_type: No Intervention
Sponsor: Insel Gruppe AG
Collaborators: IBSA Institut Biochimique SA
Drug name mappings:
name: 布洛芬
lang: CN
name: Ibuprofen
lang: EN
name: イブプロフェン
lang: JP