Injection Free IVF

NCT04850261 | Withdrawn Phase 2 DMC

• 1 other identifier: BASEC Project-ID 2020-03007
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Fertility Disorders

Keywords

In vitro fertilization, IVF; GnRHa; Ovulation induction

Outcome Measures

Primary Outcomes (2)

• Treatment tolerability

  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.

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

• Discomfort of treatment

  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.

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

Secondary Outcomes (1)

• Embryo transfer rate

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

Other Outcomes (7)

• Oocyte collection rate

  It will be reported by the IVF-laboratory 2-5 days after the follicle aspiration

• Number of mature Oocytes

  It will be reported by the IVF-laboratory 2-5 days after the follicle aspiration

• Fertilisation rate per aspirated oocyte

  It will be reported by the IVF-laboratory 2-5 days after follicle aspiration

Study Arms (2)

Intervention A: hCG injection

ACTIVE COMPARATOR

Ovulation induction by subcutaneous injection of 5.000 IU hCG

Drug: hCG Injection

Intervention B: nasal application of Nafarelin

EXPERIMENTAL

Ovulation induction by nasal application of 200 microgram Nafarelin

Drug: Nafarelin nasal spray

Interventions

hCG Injection DRUG

Ovulation will be induced by subcutaneous hCG injection

Intervention A: hCG injection

Nafarelin nasal spray DRUG

Ovulation will be induced by nasal application of Nafarelin

Intervention B: nasal application of Nafarelin

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Indication for IVF
• Wish to perform NC-IVF
• Regular menstruation cycles (26-32 days)
• Orthotopic localization of ovaries
• Age 18-42
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Officials

• Michael von Wolff, Prof.

  University Womens Hospital, Bern, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, active controlled proof-of concept trial (phase II)

Study Record Dates

• First Submitted: March 1, 2021
• First Posted: April 20, 2021
• Study Start: May 1, 2021
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share