Highly purified hMG versus recombinant FSH plus recombinant LH in intrauterine insemination cycles in women ≥35 years: a RCT.
OBJECTIVE
Is the treatment with recombinant FSH (rFSH) plus recombinant LH (rLH) more effective than highly purified (HP)-hMG in terms of ongoing pregnancy rate (PR) in women ≥35 years of age undergoing intrauterine insemination (IUI) cycles?


CONCLUSIONS
The ongoing PR was not significantly different in women treated with rFSH plus rLH or with HP-hMG.


BACKGROUND
Although previous studies have shown beneficial effects of the addition of LH activity to FSH, in terms of PR in patients aged over 34 years having ovulation induction, no studies have compared two different gonadotrophin preparations containing LH activity in women ≥35 years of age in IUI cycles.


METHODS
A single-centre RCT was performed between May 2012 and September 2013 with 579 women ≥35 years of age undergoing IUI cycles. The patients were randomly assigned to one of the two groups, rFSH in combination with rLH group or HP-hMG (Meropur) group, by giving them a code number from a computer generated randomization list, in order of enrolment. The randomization visit took place on the first day of ovarian stimulation.


METHODS
Five hundred and seventy-nine patients with unexplained infertility or mild male factor undergoing IUI cycles were recruited in a university hospital setting. All women were enrolled in this study only for one cycle of treatment. Five hundred and seventy-nine cycles were included in the final analysis. Two hundred and ninety patients were treated with rFSH in combination with rLH and 289 patients were treated with HP-hMG. The ovarian stimulation cycle started on the third day of the menstrual cycle and the starting gonadotrophin doses used were 150 IU/day of rFSH plus 150 IU/day of rLH or 150 IU/day of HP-hMG. The drug dose was adjusted according to the individual follicular response. A single IUI per cycle was performed 34-36 h after hCG injection.


RESULTS
The main outcome measures were ongoing PR and number of interrupted cycles for high risk of ovarian hyperstimulation syndrome (OHSS). Ongoing pregnancy rates were 48/290 (17.3%) in the recombinant group versus 35/289 (12.2%) in the HP-hMG group [(odds ratio (OR) 1.50, 95% CI 0.94-2.41, P = 0.09]. The number of interrupted cycles for high risk of OHSS was 13/290 (4.5%) in the rFSH plus rLH group and 2/289 (0.7%) in the HP-hMG group (OR 6.73, 95% CI 1.51-30.12, P = 0.013).


CONCLUSIONS
One of the limitations of this study was the early closure and the ongoing PR could be overestimated. Both patient and gynaecologist were informed of the assigned treatment.


CONCLUSIONS
Our results demonstrated the lack of differences in terms of ongoing PR between recombinant product and HP-hMG, in women ≥35 years undergoing controlled ovarian stimulation for IUI cycles. HP-hMG was safer than recombinant gonadotrophin concerning the risk of OHSS.


BACKGROUND
None.


BACKGROUND
NCT01604044.
Institute of Obstetrics and Gynecology, Università Cattolica del Sacro Cuore, Rome, Italy morofrancy@gmail.com.
Francesca
F
Moro
Institute of Obstetrics and Gynecology, Università Cattolica del Sacro Cuore, Rome, Italy.
Elisa
E
Scarinci
Institute of Obstetrics and Gynecology, Università Cattolica del Sacro Cuore, Rome, Italy.
Carola
C
Palla
Institute of Obstetrics and Gynecology, Università Cattolica del Sacro Cuore, Rome, Italy.
Federica
F
Romani
Institute of Obstetrics and Gynecology, Università Cattolica del Sacro Cuore, Rome, Italy.
Alessandra
A
Familiari
Institute of Obstetrics and Gynecology, Università Cattolica del Sacro Cuore, Rome, Italy.
Anna
A
Tropea
Institute of Public Health, Section of Hygiene, Università Cattolica del Sacro Cuore, Rome, Italy.
Emanuele
E
Leoncini
Institute of Obstetrics and Gynecology, Università Cattolica del Sacro Cuore, Rome, Italy.
Antonio
A
Lanzone
Institute of Obstetrics and Gynecology, Università Cattolica del Sacro Cuore, Rome, Italy.
Rosanna
R
Apa
D000328:Adult; D005260:Female; D005300:Fertility Agents, Female / Q000008:administration & dosage / Q000627:therapeutic use*; D005640:Follicle Stimulating Hormone / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D007315:Insemination, Artificial; D007986:Luteinizing Hormone / Q000008:administration & dosage / Q000627:therapeutic use*; D008596:Menotropins / Q000008:administration & dosage / Q000627:therapeutic use*; D010062:Ovulation Induction / Q000379:methods*; D011247:Pregnancy; D018873:Pregnancy Rate
D005300:Fertility Agents, Female; D008596:Menotropins; D007986:Luteinizing Hormone; D005640:Follicle Stimulating Hormone
highly purified HMG; intrauterine insemination; ovulation induction; recombinant FSH; recombinant LH