Adjuvant Growth Therapy in in Vitro Fertilization

• Status: Active, not recruiting
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

In an In Vitro Fertilization (IVF) cycle super ovulating drugs (gonadotropins) are usually taken to stimulate the ovaries to produce more than one egg. In Vitro Fertilization protocols are constantly under review in order to improve the recruitment of the follicles, which contain the eggs, whilst minimizing the doses of gonadotrophins required, with the ultimate aim of increasing the live birth rate.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinique Ovo; OVO R & D
• Collaborator: EMD Serono

Criteria

Inclusion Criteria:

• Women between the ages of 35 to 42

• Primary or secondary infertility)

• No previous treatment IVF cycle using the same proposed protocol

• Negative pregnancy test at randomization (urine or blood)

Exclusion Criteria:

• Contraindication to Saizen®

• Simultaneous participation in another clinical trial

• follicle stimulating hormone > 12 IU/L and/or anti-mullerian hormone < 0.5 pg/ml

• Body mass index ≥ 35 kg/m2

• Known risk of gestational diabetes

• Administration of any investigational medication three months prior to study enrolment

• Positive results of screening for either partner for HIV antibodies, Hepatitis B (other than surface antibodies present after vaccination) or Hepatitis C

• Not able to communicate in French or English