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Trial · Interventional

WithdrawnPhase 2Registry data

Injection Free IVF

NCTNCT04850261 (opens ClinicalTrials.gov in a new tab)Other idBASEC Project-ID 2020-03007
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Withdrawn
Phase
Phase 2
Enrollment
0 participants (actual)
Sponsor
Insel Gruppe AG, University Hospital Bern · Other
Design
Randomized · Open label (no masking)
Countries
Not stated
Start
1 May 2021 (estimated)
Primary completion
31 Mar 2024 (estimated)
Completion
31 Mar 2024 (estimated)
First posted
20 Apr 2021
Last update posted
30 Oct 2024
Conditions
Fertility Disorders

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20212022202320242025
  1. Ph 2

    Injection Free IVF

    NCT04850261

    est. 1 May 2021 to est. 31 Mar 2024

    Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Investigation of Natural Cycle In vitro Fertilisation (NC-IVF) treatment with ovulation induction with a nasal GnRH agonist instead of regular NC-IVF treatment with subcutaneous application of hCG with the objective of increasing treatment tolerability and reducing discomfort while being equally successful in terms of embryo transfer rates.

Interventions

  • hCG InjectionDrug
  • Nafarelin nasal sprayDrug

Arms2

  • Active comparator

    Intervention A: hCG injection

    Ovulation induction by subcutaneous injection of 5.000 IU hCG

  • Experimental

    Intervention B: nasal application of Nafarelin

    Ovulation induction by nasal application of 200 microgram Nafarelin

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Treatment tolerability

    Time frame · It will be assessed between Ovulation induction and follicle aspiration. It takes about 3 minutes to complete in the questionnaire

    Registry description

    Treatment tolerability will be measured with the Treatment tolerability subscale of the Fertility Quality of Life (FertiQoL) Treatment questionnaire. The subscale assesses the experience of mental and physical symptoms and disruption in daily life due to treatment. It consists of 4 items. Each item has a set of 5 possible responses, from which patients have to chose the one that most closely reflects how they think and feel.

  2. Discomfort of treatment

    Time frame · It will be assessed between Ovulation induction and follicle aspiration. It takes about 2 minutes to complete in the questionnaire

    Registry description

    The level of discomfort of the treatment encountered by the patients will be measured with 3 Visual Analogue Scale (VAS) questions ranging from 1 - 10 to specifically compare the discomfort imposed by the two treatments.

Secondary outcomes(1)

  1. Embryo transfer rate

    Time frame · It will be documented after the embryo transfer (2-5 days after follicle aspiration)

    Registry description

    Number of embryos transferred in the two groups

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 42 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Indication for IVF * Wish to perform NC-IVF * Regular menstruation cycles (26-32 days) * Orthotopic localization of ovaries * Age 18-42 * Written informed consent Exclusion Criteria: * Endometrioses III°-IV° * ≥ 3 embryo transfers in previous IVF therapies without pregnancy * Contraindications or allergies against study medications * \< 18 and \> 42 years of age * Known or suspected non-compliance * Inability of the participant to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. * Participation in another study with investigational drug within the 30 days preceding and during the present study * Previous enrolment into the current study * Enrolment of the investigators, their family members, employees and other dependent persons

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