Cumulative live birth rate of in vitro fertilization cycle via progestin-primed ovarian stimulation versus gonadotropin-releasing hormone antagonist protocol in infertile women with normal ovarian reserve: an open-label, randomized controlled trial

Figures & data

Figure 1. Flowchart of the screening and selection process in this prospective randomized controlled trial.

Table 1. Baseline characteristics.

Characteristics	PPOS with MPA (n = 174)	GnRH antagonist (n = 174)	p Value
Age (years), mean ± SD	32.12 ± 3.69	32.11 ± 4.1	0.989
BMI (kg/m^2), mean ± SD	21.85 ± 3.2	21.75 ± 3.2	0.785
Duration of infertility (years), median (interquartile range)	3 (1.5)	3 (1.5)	0.095
Primary infertility factor, n (%)	123 (70.69)	114 (65.52)	0.301
Cause of infertility, n (%)
Tube factor	93 (53.45)	90 (51.72)	0.830
Male factor	41 (23.56)	38 (21.84)	0.798
Combined factors	35 (20.11)	40 (22.99)	0.602
Unexplained factors	5 (2.88)	6 (3.45)	0.759
AFC (n), mean ± SD	9.92 ± 3.89	9.98 ± 4.22	0.885
AMH (ng/mL), mean ± SD	3.41 ± 1.73	3.63 ± 2.48	0.560
Baseline hormonal profile, mean ± SD
bFSH (mIU/mL)	7.17 ± 1.6	7.31 ± 1.76	0.440
bLH (mIU/mL)	4.22 ± 2.17	4.23 ± 2.16	0.973
bE2 (pg/mL)	40.52 ± 12.14	39.99 ± 13.5	0.701
bP (ng/mL)	0.53 ± 0.48	0.53 ± 0.52	0.887

Abbreviations: BMI: body mass index; GnRH: gonadotropin releasing hormone; MPA: medroxyprogesterone acetate; PPOS: progesterone-primed ovarian stimulation. AFC: antral follicle count; AMH: anti-Mullerian hormone.

Table 2. Outcomes of embryology and stimulate ovulation.

Parameters	PPOS with MPA (n = 174)	GnRH antagonist (n = 174)	p Value
Duration of stimulation (days), mean ± SD	9.03 ± 1.56	8.64 ± 1.75	0.029*
Total hMG dosage (IU), mean ± SD	1909.05 ± 421.77	1828.88 ± 503.77	0.108
LH-value on trigger day (mIU/mL), mean ± SD	2.30 ± 1.78	3.66 ± 3.52	0.000*
p Value on trigger day (ng/mL), mean ± SD	0.74 ± 0.41	0.99 ± 0.63	0.000*
p Value on the day after trigger (ng/mL), mean ± SD	3.80 ± 1.91	4.17 ± 2.39	0.110
Trigger drugs			0.081
GnRH-a	16.67 (29)	9.77 (17)
GnRH-a and hCG	83.33 (145)	90.23 (157)
Oocytes retrieved, mean ± SD	9.88 ± 5.31	9.14 ± 5.12	0.185
Rate of oocyte retrieval (%)	82.69 (1706/2063)	83.34 (1591/1909)	0.612
Fertilization methods			0.798
IVF(%)	76.44 (133)	78.16(136)
ICSI(%)	23.56 (41)	21.84 (38)
Metaphase stage II oocytes (n), mean ± SD	8.13 ± 4.66	7.49 ± 4.23	0.182
Best grade embryos on day 3 (n), mean ± SD	4.04 ± 2.60	3.80 ± 2.25	0.385
Viable embryos (n), mean ± SD	4.60 ± 2.58	4.44 ± 2.03	0.518
Proportion of viable embryos per oocytes (%)	46.95 (801/1706)	48.59 (773/1591)	0.348
Time interval between trigger and OPU (h), mean ± SD	36.28 ± 0.66	35.71 ± 1.74	0.001*
Premature ovulation (n)	0	0	–
Incidences of LH surge (n)	0	6	–
Severe OHSS (n)	0	0	–

Abbreviations: hMG: human menopausal gonadotropin; GnRH: gonadotropin releasing hormone; hCG: human chorionic gonadotropin; IVF: in vitro fertilization; ICSI: intracytoplasmic sperm injection; MPA: medroxyprogesterone acetate; OHSS: ovarian hyperstimulation syndrome; LH: luteinizing hormone. *p Value <0.05 is considered as significant.

Table 3. Pregnancy outcomes following frozen and fresh embryo transfer.

Outcomes	PPOS with MPA (n = 174)	GnRH antagonist (n = 174)	p Value
cLBR, %	55.75	52.87	0.591
Fresh ET cycles (n)	–	80	–
Frozen ET cycles (n)			–
No. of frozen ET1 cycles	98	55
No. of frozen ET2 cycles	30	21
No. of frozen ET3 cycles	14	6
Endometrial thickness on ET day (mm), mean ± SD
Fresh ET cycles	–	10.68 ± 1.98	–
Frozen ET cycles	10.75 ± 2.05	10.42 ± 2.08	0.169
The number of transferred embryos (%) (n/total)			0.570
Single	13.50 (27/200)	15.90 (31/195)
Two	86.50 (173/200)	84.10 (164/195)
Stages at which embryos were transferred (%) (n/total)			0.032*
Cleavage stage	90.88 (339/373)	94.99 (341/359)
Blastocyst stage	9.12 (34/373)	5.01 (18/359)
Pregnancy outcomes
Implantation rate (%)	37.27	36.77	0.939
Positive pregnancy rate (%)(n/total)	64 (128/200)	63.59 (124/195)	0.932
Clinical pregnancy rate (%) (n/total)	57 (114/200)	55.89 (109/195)	0.825
Miscarriage rate (%)(n/total)	12.28 (14/114)	13.76 (15/109)	0.742
Ectopic pregnancy rate (%)(n/total)	1.75 (2/114)	0.92 (1/109)	1.000
LBR in the different ovarian response			0.199
Low ovarian response (%)(n)	36 (9/25)	30 (9/30)
High ovarian response (%)(n)	58.62 (17/29)	52.94 (9/17)
Normal ovarian response (%)(n)	59.17(71/120)	58.27(74/127)
Twin pregnancy rate (%)(n)	22.81 (26/114)	22.94 (25/109)	0.982
Gestation (weeks), mean ± SD	38.25 ± 1.45	38.52 ± 1.68	0.762
Newborn birth weight (g), mean ± SD
Singleton	3330.27 ± 487.52	3347.64 ± 393.53	0.837
Twin	2404.63 ± 548.15	2464 ± 331.02	0.527

Abbreviations: cLBR: cumulative live birth rate; ET: embryo transfer; GnRH: gonadotropin releasing hormone; MPA: medroxyprogesterone acetate; PPOS: progesterone-primed ovarian stimulation; *p Value <0.05 is considered as significant.

Data availability statement

All data generated or analysed during this study are included in this article.