A trial to compare highly purified human menopausal gonadotropins (hMG) and recombinant follicular stimulating hormone (rFSH) to improve pregnancy rates in infertile women

A randomised open-label trial comparing highly purified human menopausal gonadotropins (hMG) and recombinant follicular stimulating hormone (rFSH) in a gonadotrophin releasing hormone (GnRH) agonist cycle for infertile women to improve pregnancy rates

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000294853

Enrollment

120

Registered

2012-03-14

Start date

2011-05-23

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Objective: Our aims were to compare hpHMG and rFSH for the duration of treatment, doses of the drugs used , the number of oocytes retrieved, the number of embryos obtained and hormonal status of the patients during ovarian stimulation. Material & methods: 120 infertility patients were recruited and randomly divided into two groups.First group used hpHMG , other group used rFSH for ovulation induction before IVF. Long protocol GnRH agonist was started at 21st day of stimulation.Transvaginal ultrasonography was performed at third and eighth day of the cycle, if ovarian cyst > 20 mm was not exist, stimulation was started. Blood samples were taken at third and eighth day of the cycle , for serum levels of estradiol (E2), progesterone (P), androstenedione (A), free testosterone (fT) and dehydroepiandrosterone sulfate (DHEA-S).When two or more follicles greater than 17 mm were observed, 10.000 IU HCG was applied inramuscularly. Follicles were collected after 36 hours from the HCG injection by transvaginal USG, using 17 gauge needles.Endometrial thickness was recorded. Aspiration of each follicle 10 millimeters and above was made. Blood samples were taken again at the day of follicle aspiration day for hormonal evaluation. All blood samples were sentrifuged and plasma was extracted immediately, and stored at '-20C'.

Interventions

120 infertility patients randomly divided in two groups. Highly purified human menopausal gonadotrophine(menopur) 150IU once a day was given to first group, recombinant FSH(Gonal F)150IU once a day was given to second group for IVF/ICSI cycles.These drugs were given every day subcutaneously, beginning from third day of menstrual cycle up to the day that two or more follicles greater than 17mm in diameter were seen by ultrasonography

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

23 Years to 36 Years

Healthy volunteers

Inclusion criteria

normal uterine anatomy having tubal factor and/or male factor or unexplained infertility Inclusion criterias, infertility duration were more than two years, whose basal FSH were between 2-12 IU/L and whose body mass indexes less than 35kg/m2 were included

Exclusion criteria

Women with previous faiure of IVF cycles, women with systemic and/or endocrine diseases, women with recurrent early pregnancy losses were excluded.

Outcome results