Sibling Oocyte Study of Medium for In Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) With no Human Serum Albumine

Sykehuset Telemark

Status and phase: Withdrawn; Phase 2

Conditions: In Vitro Fertilization; Infertility

Treatments: Other: Conventional medium; Other: Medium with no human serum albumine added

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00541892

14231(NSD)

s-05249

Details and patient eligibility

About

The purpose of this study is to determine if a new medium with no human serum albumine added is as good as the media conventionally used for IVF/ICSI.

Full description

Cells attained in IVF/ICSI procedures are kept in a medium that nurture the cells. Until now all such media have contained human serum albumine. The purpose of this study is to determine if a new medium with no human serum albumine added is as good as the media conventionally used for IVF/ICSI.

Sex: All

Ages: 18 to 38 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Couples seeking IVF/ICSI.
• Female under 38 years of age.
• No more than two previous IVF/ICSI treatments without pregnancy.
• Regular menstruation periods.
• No endocrine disease that requires treatment in the female.
• BMI below 30 in the female.
• At least 8 mature follicles upon monitoring or 6 MII oocytes upon ICSI.
• Written informed consent.

Exclusion criteria

• Low responders to FSH.
• Females in danger of developing OHSS.
• Sperm sample below ICSI-quality.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

1

Experimental group

Description:

Medium with no human serum albumine added

Treatment:

Other: Medium with no human serum albumine added

2

Active Comparator group

Description:

Conventional medium

Treatment:

Other: Conventional medium