Follicle diameter study: timing of human chorionic gonadotropin administration according to predetermined criteria of follicular size

Completed

Conditions: In Vitro Fertilisation (IVF), timing of human Chorionic Gonadotropin (hCG) administration, follicle size
Pregnancy and Childbirth
Fertilisation

Registration Number: ISRCTN24724622

Lead Sponsor: Academic Medical Centre (AMC) (The Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 400

Inclusion Criteria

1. Age between 18 and 42 and 11 months
2. Valid indication for IVF or Intra-Cytoplasmic Sperm Injection (ICSI)
3. Undergoing their first or second IVF/ICSI attempt
4. Normal Follicle-Stimulating Hormone (FSH) levels (less than 15)
5. Antral follicle count more than five for women between 40 and 43

Exclusion Criteria

1. Endocrinopathological disease as: Poly-Cystic Ovarian Syndrome (PCOS), cushing syndrome, adrenal hyperplasia, hyperprolactinaemia, acromegaly, hypothalamic amenorrhoea, hypothyroidy, diabetes mellitus type one
2. Premature ovarian failure defined as a FSH level on cycle-day three of more than or equal to 15 IU at the age of 40
3. Low responders defined as follicle growth of less than three follicles during controlled ovarian hyperstimulation (including the dominant follicle)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate, defined as a positive foetal heartbeat by ultrasound at ten weeks after oocyte retrieval.

Secondary Outcome Measures

Name	Time	Method
1. Endometrium thickness, three-layer aspect<br>2. Total days of controlled hyper stimulation<br>3. Total amount of recombinant FSH (rFSH) used<br>4. Total number of retrieved oocytes<br>5. Number of score one oocytes (IVF only)<br>6. Number of metaphase two oocytes (ICSI only)<br>7. Fertilisation rate<br>8. Number and quality of embryos<br>9. Pronuclear morphology<br>10. Presence of early cleavage<br>11. Daily morphological quality of embryos until transfer<br>12. Number of embryos suited for cryo-preservation<br>13. Ovarian Hyper-Stimulation Syndrome (OHSS)/discontinuation due a high risk of OHSS<br>14. Biochemical and clinical pregnancy rates, defined as a increase in serum hCG or a positive pregnancy test and positive heartbeat by ultrasound at seven weeks after oocyte retrieval, respectively