Comparison Between PPOS and GnRHa-Long Protocol in Clinical Outcome with the First IVF/ICSI Cycle: A Randomized Clinical Trial

Figures & data

Figure 1 A flow chart of the patient allocation in an RCT of PPOS versus GnRHa-long protocol.

Abbreviations: PPOS, progesterone-primed ovarian stimulation; MPA, medroxyprogesterone acetate; ET, fresh embryo transfer; FET, frozen embryo transfer.

Figure 2 Concentrations of FSH, LH, E2, and P in the two groups during controlled ovarian stimulation. Abbreviations: FSH, follicle-stimulating hormone; LH, luteinizing hormone; E2estrogen; P, progesterone.

Table 1 The Basic Characteristics of Women Undergoing IVF/ICSI Treatment in the Two Ovarian Stimulation Groups

Baseline Characteristics	Study Group (PPOS; n=130)	Control (GnRHa-Long Protocol; n=127)	P value
Age(years), mean(SD)	31.4(4.0)	31.6(4.2)	0.81
BMI(kg/m^2), mean(SD)	21.5(2.5)	21.49(2.7)	0.86
Duration of infertility(years), mean(SD)	2.9(2.5)	2.97(2.5)	0.64
Primary infertility, n(%)	54.6%(71/130)	46.5%(59/127)	0.19
Insemination method			0.73
IVF	91	84
ICSI	19	23
IVF+ICSI	20	20

Note: The differences were considered statistically significant when the p-value was less than 0.05.

Abbreviations: BMI, body mass index; IVF, in vitro fertilization; ICSI, intracytoplasmic sperm injection.

Table 2 The Cycle Characteristics of Controlled Ovarian Stimulation in Two Regimens

Characteristic	Study Group (PPOS; n=130)	Control Group (GnRHa-Long Protocol; n=127)	P value
AFC on 1st day of stimulation, mean(SD)	12.3(4.6)	11.7(5.0)	0.35
>10 mm follicles on hCG administration day, mean(SD)	13.7(6.2)	14.7(7.1)	0.28
>14 mm follicles on hCG administration day (n), mean(SD)	10.2(5.7)	10.6(6.5)	0.95
hMG duration, mean(SD)	9.1(1.3)	11.9(2.3)	0.00
hMG dose, mean(SD)	2027.9(333.9)	2672.8(599.5)	0.00
Incidence of premature LH surge (%)	0/130	0/127
Moderate or severe OHSS (%)	0%(0/130)	2.36%(3/127)	0.24

Note: The differences were considered statistically significant when the p-value was less than 0.05.

Abbreviations: AFC, antral follicle count; LH, luteinizing hormone; OHSS, ovarian hyperstimulation syndrome.

Table 3 The Embryological Outcomes of Controlled Ovarian Stimulation in Two Regimens

Characteristic	Study Group (PPOS; n=130)	Control Group (GnRHa-Long Protocol; n=127)	P value
Oocytes retrieved, mean(SD)	11.8(6.5)	11.3(5.6)	0.81
MII oocytes, mean(SD)	10.3(5.8)	10.1(5.2)	0.95
Fertilized oocytes, mean(SD)	9.1(5.6)	9.0(5.2)	1.00
Cleaved embryos, mean(SD)	8.0(4.8)	7.5(4.5)	0.47
Top-quality embryos, mean(SD)	3.9(3.0)	3.4(2.5)	0.19
Viable embryos, mean(SD)	4.5(3.0)	4.2(2.9)	0.25
Oocyte retrieval rate (%)	71.3%(1534/2151)	68.6%(1430/2085)	0.05
Mature oocyte rate (%)	87.3%(1339/1534)	89.3%(1277/1430)	0.09
Fertilization rate (%)	77.3%(1186/1534)	79.8%(1141/1430)	0.10
Cleavage rate (%)	97.5%(1035/1062)	96.5%(948/982)	0.22
Viable embryo rate per oocyte retrieved (%)	38.2%(586/1534)	37.5%(536/1430)	0.69
Cancellation rate (%)	6.2%(8/130)	4.7%(6/127)	0.61

Note: The differences were considered statistically significant when the p-value was less than 0.05.

Table 4 Hormone Profiles During Ovarian Stimulation in the Two Groups

Characteristic	Study Group (PPOS; n=130)	Control Group (GnRHa-Long Protocol; n=127)	P value
Hormones on 1st day of stimulation
FSH(IU/L), mean(SD)	5.8(1.2)	2.9(1.4)	0.00
LH(IU/L), mean(SD)	3.6(1.4)	0.4(0.3)	0.00
E2(IU/L), mean(SD)	39.1(16.5)	15.0(6.3)	0.00
P(IU/L), mean(SD)	0.3(0.2)	0.2(0.1)	0.00
Hormones on trigger day
FSH(IU/L), mean(SD)	16.4(4.6)	15.0(3.6)	0.03
LH(IU/L), mean(SD)	1.9(1.0)	0.7(0.5)	0.00
E2(pg/mL), mean(SD)	3639.6(1302.8)	3297.5(1506.5)	0.07
P(ng/mL), mean(SD)	0.7(0.4)	0.8(0.6)	0.62
E2 per >10mm follicles, mean(SD)	284.2(92.6)	229.2(74.5)	0.00
E2 per >14mm follicles, mean(SD)	409.2(174.6)	356.5(163.9)	0.01
E2 per MII oocytes, mean(SD)	443.3(372.6)	377.6(231.3)	0.02

Note: The differences were considered statistically significant when the p-value was less than 0.05.

Abbreviations: FSH, follicle-stimulating hormone; LH, luteinizing hormone; E2, estrogen; P, progesterone.

Table 5 Pregnancy Outcomes of the First ET/FET Cycles Originating from the Two Regimens

	Study Group (PPOS)	Control Group (GnRHa-Long Protocol)	P value*
Patients(n)	115	121
ET/FET cycles(n)	115	121
Embryo before thawed	221	235
Viable embryo after thawed	221	235
Transferred embryos per cycle, mean(SD)	1.9(0.3)	1.94(0.2)	0.53
Single embryo transfer, n (%)	9(7.8)	7(5.8)	0.53
Double embryo transfer, n (%)	106(92.2)	114(94.2)
Endometrial preparation (n)			0.00
GnRHa long protocol	0	98
Natural cycle	32	4
Mild stimulation	78	17
Hormone replacement therapy	5	2
Endometrial thickness(mm), mean(SD)	11.5(2.4)	12.25(2.6)	0.02
Pregnancy outcome(%)
Biochemical pregnancy rate per transfer	59.1%(68/115)	62.0%(75/121)	0.65
Clinical pregnancy rate per transfer	56.5%(65/115)	57.0%(69/121)	0.94
Implantation rate	38.0%(84/221)	39.2%(92/235)	0.80
Early miscarriage rate	4.6%(3/65)	8.7%(6/69)	0.55
Multiple pregnancy rate	27.7%(18/65)	30.4%(21/69)	0.73
Ectopic pregnancy rate	3.1%(2/65)	2.9%(2/69)	1.00
Intrauterine and ectopic pregnancy rate	1.5%(1/65)	0%(0/69)	0.49
Ongoing pregnant rate per transfer	51.3%(59/115)	50.4%(61/121)	0.89

Note: *The differences were considered statistically significant when the p-value was less than 0.05.

Abbreviations: ET, fresh embryo transfer; FET, frozen embryo transfer.

Table 6 Pregnancy Outcomes of the First FET Cycles Originating from the Two Groups

Outcome	Study Group (PPOS)	Control Group (GnRHa-Long Protocol)	P value
Patients(n)	115	23
ET/FET cycles(n)	115	23
Embryo before thawed	221	45
Viable embryo after thawed	221	45
Transferred embryos per cycle(n)	1.9(0.3)	2.0(0.2)	0.56
Single embryo transfer, n (%)	9(7.8)	1(4.3)	0.88
Double embryo transfer, n (%)	106(92.2)	22(95.7)
Endometrial preparation (n)			0.45
Natural cycle	32	4
Mild stimulation	78	17
Hormone replacement therapy	5	2
Endometrial thickness(mm)	11.5(2.4)	11.0(1.8)	0.53
Pregnancy outcome(%)
Biochemical pregnancy rate per transfer	59.1%(68/115)	69.6%(16/23)	0.35
Clinical pregnancy rate per transfer	56.5%(65/115)	69.6%(16/23)	0.25
Implantation rate	38.0%(84/221)	48.9%(22/45)	0.17
Early miscarriage rate	4.6%(3/65)	12.5%(2/16)	0.26
Multiple pregnancy rate	27.7%(18/65)	37.5%(6/16)	0.64
Ectopic pregnancy rate	3.1%(2/65)	6.3%(1/16)	0.49
Intrauterine and ectopic pregnancy rate	1.5%(1/65)	0.0%(0/16)	1.00
Ongoing pregnant rate per transfer	51.3%(59/115)	56.5%(13/23)	0.65

Note: The differences were considered statistically significant when the p-value was less than 0.05.

Abbreviations: ET, fresh embryo transfer; FET, frozen embryo transfer.