This is a phase 3b clinical trial with follitropin delta (FE 999049) and Gonal-F. The trial is a randomised, controlled, assessor-blind, parallel groups, multicentre trial comparing the ovarian response of a starting dose of either 10mg or 15 mg follitropin delta to a starting dose of either 150 IU or 225 IU Gonal-F in a long GnRH agonist protocol in women undergoing an assisted reproductive technology programme in China.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
301
FE 999049 was administered as single daily subcutaneous injections at a starting dose of either 10 or 15 µg daily that was fixed for the first five stimulation days. Based on ovarian response, the dose could be increased or decreased by 5 µg, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 5 µg, and the maximum daily dose was 20 µg. Participants could be treated for a maximum of 20 days.
GONAL-F was administered as single daily subcutaneous injections at a starting dose of either 150 or 225 IU daily that was fixed for the first five stimulation days. Based on ovarian response, the dose could be increased or decreased by 75 IU, with dose adjustments implemented not more frequently than once every 2 days per investigator's judgement. The minimum daily dose was 75 IU, and the maximum daily dose was 300 IU. Participants could be treated for a maximum of 20 days. Coasting was not allowed.
Ferring Investigational Site
Shushan, Anhui, China
Ferring Investigational Site
Yuzhong, Chongqing Municipality, China
Ferring Investigational Site
Guangzhou, Guandong, China
Ferring Investigational Site
Guangzhou, Guangdong, China
Ferring Investigational Site
Zhengzhou, Henan, China
Ferring Investigational Site
Nanchang, Jiangxi, China
Ferring Investigational Site
Shengyang, Liaoling, China
Ferring Investigational Site
Shanghai, Shanghai Municipality, China
Ferring Investigational Site
Chengdu, Sichuang, China
Ferring Investigational Site
Tianjin, Tianjin Municipality, China
...and 1 more locations
Number of Oocytes Retrieved
Time frame: On day of oocyte retrieval (up to 22 days after start of stimulation)
Number of Follicles on Stimulation Day 6 and End-of-stimulation
Time frame: Stimulation day 6 and end-of-stimulation (maximum stimulation day 20)
Serum Concentrations of Estradiol on Stimulation Day 6 and End-of-stimulation
Time frame: stimulation day 6 and end-of-stimulation (maximum stimulation day 20)
Serum Concentrations of Progesterone on Stimulation Day 6 and End-of-stimulation
Time frame: stimulation day 6 and end-of-stimulation (maximum stimulation day 20)
Number of Fertilised Oocytes
Time frame: On day 1 after oocyte retrieval (up to 23 days after start of stimulation)
Fertilisation Rate
Time frame: On day 1 after oocyte retrieval (up to 23 days after start of stimulation)
Number of Embryos (Total and Quality)
Time frame: Day 3 after oocyte retrieval
Total Gonadotropin Dose
Time frame: Up to 20 stimulation days
Number of Stimulation Days
Time frame: Up to 20 stimulation days
Positive βhCG (Positive Serum βhCG Test 13-15 Days After Transfer) Rate
Time frame: 13-15 days after transfer
Clinical Pregnancy (at Least One Gestational Sac 5-6 Weeks After Transfer) Rate
Time frame: 5-6 weeks after transfer
Vital Pregnancy (at Least One Intrauterine Gestational Sac With Fetal Heart Beat 5-6 Weeks After Transfer) Rate
Time frame: 5-6 weeks after transfer
Implantation Rate
The implantation rate was defined as the number of gestational sacs 5-6 weeks after transfer divided by number of embryos transferred.
Time frame: 5-6 weeks after transfer
Ongoing Pregnancy (at Least One Intrauterine Viable Fetus 10-11 Weeks After Transfer) Rate
Time frame: 10-11 weeks after transfer
Ongoing Implantation Rate (Number of Intrauterine Viable Fetuses 10-11 Weeks After Transfer Divided by Number of Embryos Transferred)
The ongoing implantation rate was defined as the number of intrauterine viable fetuses 10-11 weeks after transfer divided by the number of embryos transferred.
Time frame: 10-11 weeks after transfer
Early Ovarian Hyperstimulation Syndrome (OHSS), Late OHSS, and Total OHSS (All Overall and by Grade)
Early OHSS was defined as OHSS with onset ≤9 days after triggering of final follicular maturation. Late OHSS was defined as OHSS with onset \>9 days after triggering of final follicular maturation. Total OHSS measure the incidence of OHSS both early and late.
Time frame: ≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation until 21-28 days after last IMP dose or up to ongoing pregnancy 8-9 weeks after transfer in pregnant participants (late OHSS)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.